Healthy Adult Subjects
Conditions
Brief summary
Complex oligosaccharides can alter the gut microbiome by aiding in the growth of certain organisms, and possibly, inhibiting others. The synergy with a probiotic may enhance gastrointestinal colonization.
Detailed description
The study will evaluate the synergy of the use of a complex oligosaccharide with and without a probiotic on the human microbiome in healthy volunteers. The combination should support general gastrointestinal health. The study a multi-dose randomized cohort trial using 10 subjects per cohort for a total of 60 healthy adult volunteers ages 18-44.
Interventions
DIETARY_SUPPLEMENTComplex oligosaccharide
Complex oligosaccharide concentrate
DIETARY_SUPPLEMENTProbiotic
Probiotic
OTHERPPI
Over-the-counter proton pump inhibitor (PPI)
OTHERH2 Blocker
Over-the-counter H2 blocker
Sponsors
Prolacta Bioscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults between the ages of 18-44 years * Willingness to complete all study procedures and clinic visits, and provide required samples * Provides informed consent
Exclusion criteria
* Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study * Subjects with history of lactose intolerance * Subjects who are on a PPI regimen * Subjects who have taken a probiotic during the previous 30 days, or intends to take a probiotic during the study. * Subjects who have taken antibiotics within 120 days * Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening * Unstable medical condition, in the opinion of the investigator * Clinically significant abnormal laboratory test results at screening * Participation in a clinical research trial within 30 days prior to screening * Unable to give informed consent * Any condition which may preclude subject's ability to comply with and complete the study or may pose a risk to the health of the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57 | qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Day 1 - 15 | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. |
| Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57 | Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA). |
| Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Day 1, 8, 15, 29 | Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 & 6 combined; 18g HMO + B. infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples. |
| Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Day 1 - 15 | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose. |
| Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Day 1 - 15 | Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Probiotic) Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily | 10 |
| Cohort 2 (Complex Oligosaccharide) Day 1-14: Subjects receive 18 g dose of complex oligosaccharide orally twice daily | 10 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 4.5 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 4.5 g dose of complex oligosaccharide orally twice daily | 10 |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 9 g dose of complex oligosaccharide orally twice daily Day 8-14:Subjects receive only 9 g dose of complex oligosaccharide orally twice daily | 10 |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) First Course Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) and PPI orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
Second Course Day 29-35: Subjects receive standard probiotic dose (mixed in aqueous diluent) and may receive H2 blocker\* orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 36-42: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily
\*4 subjects received H2 blocker, 4 subjects did not receive H2 blocker during second course | 12 |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) Day 1-7: Subjects receive standard probiotic dose (mixed in aqueous diluent) orally once daily in combination with 18 g dose of complex oligosaccharide orally twice daily Day 8-14: Subjects receive only 18 g dose of complex oligosaccharide orally twice daily | 10 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | Cohort 1 (Probiotic) | Cohort 2 (Complex Oligosaccharide) | Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 12 Participants | 10 Participants |
| Age, Continuous | 33.5 years STANDARD_DEVIATION 6.5 | 34.8 years STANDARD_DEVIATION 7 | 34.6 years STANDARD_DEVIATION 4.4 | 31.7 years STANDARD_DEVIATION 8.2 | 34.1 years STANDARD_DEVIATION 6.4 | 31.1 years STANDARD_DEVIATION 6.9 | 34.6 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 0 Participants | 7 Participants | 3 Participants | 3 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 10 Participants | 3 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin | 14.3 g/dL STANDARD_DEVIATION 1.69 | 14.2 g/dL STANDARD_DEVIATION 2.45 | 14.3 g/dL STANDARD_DEVIATION 1.88 | 13.7 g/dL STANDARD_DEVIATION 1.51 | 14.2 g/dL STANDARD_DEVIATION 1.62 | 14.8 g/dL STANDARD_DEVIATION 1.4 | 14.6 g/dL STANDARD_DEVIATION 1.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 5 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 5 Participants | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 0 Participants | 5 Participants | 6 Participants | 4 Participants | 6 Participants | 5 Participants |
| Region of Enrollment United States | 62 participants | 10 participants | 10 participants | 10 participants | 10 participants | 12 participants | 10 participants |
| Sex: Female, Male Female | 26 Participants | 5 Participants | 5 Participants | 6 Participants | 4 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 36 Participants | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 1 / 10 | 2 / 10 | 1 / 10 | 2 / 12 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 12 | 0 / 10 |
Outcome results
Primary
Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR
qPCR analysis uses primers for species and strain on DNA extracted from stool samples and is reported as genome copies per nanogram of DNA. The higher the value, the greater indication of engraftment of B.infantis signal over time indicating retention of introduced species.
Time frame: All Cohorts - Day 1, 5, 8, 15 and 29; Cohort 5 - additionally Days 33, 36, 43, 50 and 57
Population: Changes in microbiome species abundance and diversity
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 (Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 1 | 3.33 copies/ng DNA |
| Cohort 1 (Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 8 | 276.67 copies/ng DNA |
| Cohort 1 (Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 15 | 5.36 copies/ng DNA |
| Cohort 1 (Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 5 | 322.38 copies/ng DNA |
| Cohort 1 (Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 22 | 3.33 copies/ng DNA |
| Cohort 1 (Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 29 | 3.33 copies/ng DNA |
| Cohort 2 (Complex Oligosaccharide) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 29 | 3.33 copies/ng DNA |
| Cohort 2 (Complex Oligosaccharide) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 15 | 3.33 copies/ng DNA |
| Cohort 2 (Complex Oligosaccharide) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 22 | 3.33 copies/ng DNA |
| Cohort 2 (Complex Oligosaccharide) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 5 | 3.33 copies/ng DNA |
| Cohort 2 (Complex Oligosaccharide) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 8 | 3.33 copies/ng DNA |
| Cohort 2 (Complex Oligosaccharide) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 1 | 3.33 copies/ng DNA |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 15 | 21.83 copies/ng DNA |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 1 | 3.33 copies/ng DNA |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 5 | 127.48 copies/ng DNA |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 8 | 271.21 copies/ng DNA |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 22 | 3.33 copies/ng DNA |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 29 | 3.33 copies/ng DNA |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 15 | 18.89 copies/ng DNA |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 8 | 180.24 copies/ng DNA |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 1 | 3.33 copies/ng DNA |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 22 | 3.33 copies/ng DNA |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 29 | 3.33 copies/ng DNA |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 5 | 64.03 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 22 | 3.33 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 15 | 111.46 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 1 | 3.33 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 57 | 3.33 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 5 | 263.20 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 29 | 3.33 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 33 | 59.74 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 36 | 72.34 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 43 | 22.96 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 8 | 391.72 copies/ng DNA |
| Cohort 5 (18 g Dose of Complex Oligosaccharide + PPI + Probiotic +/- H2 Blocker) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 50 | 4.07 copies/ng DNA |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 8 | 1454.29 copies/ng DNA |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 15 | 1636.68 copies/ng DNA |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 5 | 371.37 copies/ng DNA |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 1 | 3.33 copies/ng DNA |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 22 | 9.13 copies/ng DNA |
| Cohort 6 (18 g Dose of Complex Oligosaccharide + Probiotic) | Evaluation of the Levels of B.Infantis in Stool by Quantitative PCR | Day 29 | 3.33 copies/ng DNA |
p-value: <0.0001Mixed Models Analysis
Secondary
Changes in Concentration of Blood Parameters From Day 1 to Day 15
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Time frame: Day 1 - 15
Population: Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantification. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Measurements were only taken for Cohorts 1, 2 and 6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 beta (IL-1 beta) - Study Day 1 | 10.90 pg/mL | Standard Deviation 2.32 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Brain-Derived Neurotrophic Factor (BDNF) - Study Day 15 | 13.43 pg/mL | Standard Deviation 6.06 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Eotaxin-2 - Study Day 1 | 928.70 pg/mL | Standard Deviation 261.85 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Eotaxin-2 - Study Day 15 | 931.80 pg/mL | Standard Deviation 289.66 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Brain-Derived Neurotrophic Factor (BDNF) - Study Day 1 | 14.10 pg/mL | Standard Deviation 5.38 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 beta (IL-1 beta) - Study Day 15 | 9.75 pg/mL | Standard Deviation 3.91 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 receptor antagonist (IL-1ra) - Study Day 1 | 108.80 pg/mL | Standard Deviation 30.44 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 receptor antagonist (IL-1ra) - Study Day 15 | 118.90 pg/mL | Standard Deviation 17.76 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-12 Subunit p40 (IL-12p40) - Study Day 1 | 0.66 pg/mL | Standard Deviation 0.17 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-12 Subunit p40 (IL-12p40) - Study Day 15 | 0.69 pg/mL | Standard Deviation 0.14 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-18 (IL-18) - Study Day 1 | 207.10 pg/mL | Standard Deviation 124.68 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-18 (IL-18) - Study Day 15 | 187.20 pg/mL | Standard Deviation 100.18 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 1 | 35.20 pg/mL | Standard Deviation 6 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 15 | 34.70 pg/mL | Standard Deviation 7.41 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 1 | 427.80 pg/mL | Standard Deviation 184.1 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 15 | 430.60 pg/mL | Standard Deviation 222.27 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Vascular Endothelial Growth Factor (VEGF) - Study Day 1 | 288.70 pg/mL | Standard Deviation 112.99 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Vascular Endothelial Growth Factor (VEGF) - Study Day 15 | 303.70 pg/mL | Standard Deviation 125.31 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Vascular Endothelial Growth Factor (VEGF) - Study Day 15 | 252.78 pg/mL | Standard Deviation 117.2 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Brain-Derived Neurotrophic Factor (BDNF) - Study Day 1 | 17.36 pg/mL | Standard Deviation 5.92 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-12 Subunit p40 (IL-12p40) - Study Day 15 | 0.60 pg/mL | Standard Deviation 0.22 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 1 | 33.90 pg/mL | Standard Deviation 4.91 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Brain-Derived Neurotrophic Factor (BDNF) - Study Day 15 | 16.82 pg/mL | Standard Deviation 4.34 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 1 | 390.30 pg/mL | Standard Deviation 275.65 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 15 | 408.11 pg/mL | Standard Deviation 295.14 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Eotaxin-2 - Study Day 1 | 1129.50 pg/mL | Standard Deviation 247.49 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-18 (IL-18) - Study Day 1 | 208.00 pg/mL | Standard Deviation 77.16 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Vascular Endothelial Growth Factor (VEGF) - Study Day 1 | 233.60 pg/mL | Standard Deviation 79.24 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Eotaxin-2 - Study Day 15 | 1214.00 pg/mL | Standard Deviation 304.64 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-12 Subunit p40 (IL-12p40) - Study Day 1 | 0.60 pg/mL | Standard Deviation 0.17 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 15 | 35.33 pg/mL | Standard Deviation 5.89 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 beta (IL-1 beta) - Study Day 1 | 9.90 pg/mL | Standard Deviation 4.22 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 receptor antagonist (IL-1ra) - Study Day 15 | 111.22 pg/mL | Standard Deviation 36.89 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-18 (IL-18) - Study Day 15 | 223.22 pg/mL | Standard Deviation 92.55 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 beta (IL-1 beta) - Study Day 15 | 10.50 pg/mL | Standard Deviation 4.46 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 receptor antagonist (IL-1ra) - Study Day 1 | 118.90 pg/mL | Standard Deviation 27.52 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 beta (IL-1 beta) - Study Day 15 | 10.68 pg/mL | Standard Deviation 2.07 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 receptor antagonist (IL-1ra) - Study Day 1 | 108.33 pg/mL | Standard Deviation 26.83 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 receptor antagonist (IL-1ra) - Study Day 15 | 104.00 pg/mL | Standard Deviation 25.09 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 1 | 329.22 pg/mL | Standard Deviation 161.56 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-12 Subunit p40 (IL-12p40) - Study Day 1 | 0.65 pg/mL | Standard Deviation 0.08 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Vascular Endothelial Growth Factor (VEGF) - Study Day 15 | 198.22 pg/mL | Standard Deviation 89.24 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-12 Subunit p40 (IL-12p40) - Study Day 15 | 0.67 pg/mL | Standard Deviation 0.17 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-18 (IL-18) - Study Day 1 | 187.33 pg/mL | Standard Deviation 79.43 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Macrophage Inflammatory Protein-1 beta (MIP-1 beta) - Study Day 15 | 335.44 pg/mL | Standard Deviation 148.03 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-18 (IL-18) - Study Day 15 | 180.00 pg/mL | Standard Deviation 85.23 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Brain-Derived Neurotrophic Factor (BDNF) - Study Day 1 | 16.30 pg/mL | Standard Deviation 4.51 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Brain-Derived Neurotrophic Factor (BDNF) - Study Day 15 | 16.00 pg/mL | Standard Deviation 3.94 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 1 | 30.67 pg/mL | Standard Deviation 10.46 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Eotaxin-2 - Study Day 1 | 1004.89 pg/mL | Standard Deviation 362.32 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Eotaxin-2 - Study Day 15 | 1112.78 pg/mL | Standard Deviation 437.58 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Interleukin-1 beta (IL-1 beta) - Study Day 1 | 9.28 pg/mL | Standard Deviation 4.12 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Latency-Associated Peptide of Transforming Growth Factor beta 1 (LAP TGF-b1) - Study Day 15 | 32.11 pg/mL | Standard Deviation 8.54 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 | Vascular Endothelial Growth Factor (VEGF) - Study Day 1 | 200.11 pg/mL | Standard Deviation 95.08 |
Secondary
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII)
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function, and electrolytes and glucose.
Time frame: Day 1 - 15
Population: Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantitation. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Data were only available for Cohorts 1, 2 and 6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Factor VII - Day 1 | 354.0 ug/mL | Standard Deviation 104 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Factor VII - Day 15 | 358.5 ug/mL | Standard Deviation 124.7 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Factor VII - Day 1 | 382.9 ug/mL | Standard Deviation 90 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Factor VII - Day 15 | 403.6 ug/mL | Standard Deviation 99.6 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Factor VII - Day 1 | 362.3 ug/mL | Standard Deviation 76 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (Factor VII) | Factor VII - Day 15 | 384.2 ug/mL | Standard Deviation 79.5 |
Secondary
Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1)
Blood samples are collected and tested for analysis of the levels of cytokines using Luminex-based chemistry to assess for immunology screening and safety monitoring of liver function, renal function and electrolytes and glucose.
Time frame: Day 1 - 15
Population: Descriptive statistics will not include analytes that were not detected in samples or not detected at high enough concentrations to be above the lower limit of quantification. Values for analytes below the lower limit of quantification were imputed with that value for inclusion in the descriptive statistics. Data were only available for Cohorts 1, 2 and 6.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Intercellular Adhesion Molecule 1 (ICAM-1) - Day 1 | 71.0 ng/mL | Standard Deviation 18.4 |
| Cohort 1 (Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Intercellular Adhesion Molecule 1 (ICAM-1) - Day 15 | 65.2 ng/mL | Standard Deviation 16.2 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Intercellular Adhesion Molecule 1 (ICAM-1) - Day 1 | 68.6 ng/mL | Standard Deviation 23.5 |
| Cohort 2 (Complex Oligosaccharide) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Intercellular Adhesion Molecule 1 (ICAM-1) - Day 15 | 75.1 ng/mL | Standard Deviation 28.6 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Intercellular Adhesion Molecule 1 (ICAM-1) - Day 15 | 73.0 ng/mL | Standard Deviation 27.5 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Changes in Concentration of Blood Parameters From Day 1 to Day 15 (ICAM-1) | Intercellular Adhesion Molecule 1 (ICAM-1) - Day 1 | 65.1 ng/mL | Standard Deviation 21.8 |
Secondary
Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29
Descriptive statistics including means and standard deviation of lactate (Cohort 1; 0g HMO + B. infantis, Cohort 2; 18 g HMO, engrafted subjects and not engrafted subjects from Cohorts 5 & 6 combined; 18g HMO + B. infantis). Descriptive statistics will not include analytes that were not detected in greater than 50% of samples.
Time frame: Day 1, 8, 15, 29
Population: Cohort 1 (no HMO, only B. infantis), Cohort 2 (18g HMO, no B. infantis). Cohorts 5 and 6 were combined because both of these groups received 18g HMO +B. infantis and this was pre-specified in the analysis plan for this outcome. The measurement of lactic acid was expected, therefore, to be very similar between these two groups and the goal of this analysis was to compare the combination of a probiotic with complex oligosaccharides to each of these separately (Cohorts 1 and 2, respectively).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 1 | 0.11 µmol/g | Standard Deviation 0.04 |
| Cohort 1 (Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 8 | 0.18 µmol/g | Standard Deviation 0.14 |
| Cohort 1 (Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 15 | 0.13 µmol/g | Standard Deviation 0.11 |
| Cohort 1 (Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 29 | 0.18 µmol/g | Standard Deviation 0.14 |
| Cohort 2 (Complex Oligosaccharide) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 8 | 0.20 µmol/g | Standard Deviation 0.2 |
| Cohort 2 (Complex Oligosaccharide) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 15 | 0.14 µmol/g | Standard Deviation 0.06 |
| Cohort 2 (Complex Oligosaccharide) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 29 | 0.13 µmol/g | Standard Deviation 0.05 |
| Cohort 2 (Complex Oligosaccharide) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 1 | 0.39 µmol/g | Standard Deviation 0.74 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 15 | 0.85 µmol/g | Standard Deviation 1.14 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 8 | 0.17 µmol/g | Standard Deviation 0.05 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 29 | 0.40 µmol/g | Standard Deviation 0.93 |
| Cohort 3 (4.5 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 1 | 3.18 µmol/g | Standard Deviation 10.02 |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 29 | 0.12 µmol/g | Standard Deviation 0.06 |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 8 | 0.16 µmol/g | Standard Deviation 0.08 |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 1 | 0.14 µmol/g | Standard Deviation 0.05 |
| Cohort 4 (9 g Dose of Complex Oligosaccharide + Probiotic) | Concentrations (µmol/g) of Lactic Acid in Stool Samples From Day 1 to Day 29 | Lactic acid - Day 15 | 0.12 µmol/g | Standard Deviation 0.06 |
Secondary
Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit
Evaluation of B. infantis levels in Dose Group 5 will be compared to B. infantis levels in Dose Groups 6 using descriptive statistics including geometric means and 95% confidence intervals of the genome copy number per nanogram of DNA (B. infantis copies/ng DNA).
Time frame: Day 1, 5, 8, 15, 22, 29, 33, 43, 50, 57
Population: Microbiome Population (Two cohorts received 18g of HMO with B. infantis and will be distinguished from each other by one receiving the proton pump inhibitor omeprazole. In addition, the cohort dosed with omeprazole received a second round of dosing with half of the subjects receiving famotidine in addition to B. infantis and 18g of HMO and the remainder not receiving any acid reducing drugs)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 57 | 3.3 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 29 | 3.3 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 33 | 59.7 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 36 | 72.3 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 43 | 23.0 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 50 | 4.1 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 1 | 3.3 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 5 | 263.2 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 8 | 391.7 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 15 | 111.5 B. infantis (copies/ng DNA) |
| Cohort 1 (Probiotic) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 22 | 3.3 B. infantis (copies/ng DNA) |
| Cohort 2 (Complex Oligosaccharide) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 1 | 3.3 B. infantis (copies/ng DNA) |
| Cohort 2 (Complex Oligosaccharide) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 15 | 1636.7 B. infantis (copies/ng DNA) |
| Cohort 2 (Complex Oligosaccharide) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 5 | 371.4 B. infantis (copies/ng DNA) |
| Cohort 2 (Complex Oligosaccharide) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 29 | 3.3 B. infantis (copies/ng DNA) |
| Cohort 2 (Complex Oligosaccharide) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 8 | 1454.3 B. infantis (copies/ng DNA) |
| Cohort 2 (Complex Oligosaccharide) | Summary of the Evaluation of the Use of Proton Pump Inhibitors for Protection of B. Infantis Levels in Cohorts 5 and 6 by Visit | Day 22 | 9.1 B. infantis (copies/ng DNA) |