Healthy Adults
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 who have received antibiotics. The combination should support general gastrointestinal health. This study is a multi-dose randomized cohort trial using 18 subjects per cohort for a total of 90 healthy adult volunteers ages 18-75.
Interventions
DIETARY_SUPPLEMENTHMO Concentrate
Concentrated milk fortifiers from donor human milk
DIETARY_SUPPLEMENTProbiotic
B. infantis
DIETARY_SUPPLEMENTFood Supplement
Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT)
DIETARY_SUPPLEMENTAntibiotic
Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Sponsors
Prolacta Bioscience
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Healthy adults between the ages of 18-75 years (subjects must be 18-75 at the time of consent) who can provide proof of vaccination against SARS-CoV-2. Proof may be a physical or electronic record of vaccination or self-attestation (to include approximate vaccination date and manufacturer of vaccine) if a copy of the vaccination record is not available * Subjects must have a BMI of 18 - 30 at screening visit * Willingness to complete study specific questionnaires * Willingness to complete journal to record IP dosing times, Bristol stool scores, and IP flavor questionnaires * Willingness to complete all study procedures, clinic visits, and provide required biospecimen samples * Willingness to collect and process stool samples at home and transport stool samples to clinic * Sexually active females of child-bearing potential must agree to use highly effective methods of contraception during heterosexual intercourse throughout the study period and for three days following discontinuation of IP, whichever comes later. Examples of highly effective methods include the use of two forms of contraception with one being an effective barrier method (e.g., a condom and spermicide used together), or have a vasectomised partner. Abstinence is acceptable as a life-style choice. Female subjects who utilize hormonal contraceptives as one of their birth control methods must have used the same method for at least 3 months before study dosing * Provide informed consent
Exclusion criteria
* Subjects with a BMI of 17 or less or 31 or greater are excluded * Women who are pregnant or breastfeeding, or intend to become pregnant during the course of this study * Subjects who intend to take a probiotic during the study * Subjects with self-reported diarrhea on day 1 prior to dosing, whereby diarrhea is defined as two or more episodes of watery and/or unformed stool within 24 hours * Alcohol or drug abuse during the last 12 months, including passing a screen for drugs of abuse at screening and day 1 of the study * Unstable medical condition, in the opinion of the investigator * Subject with a history of allergy to the study antibiotics * Clinically significant abnormal laboratory test results at screening * Subjects who are unable or unwilling to provide stool samples on a regular basis as per study protocol * 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 * Known carriers of C. difficile prior to study start, as determined by qPCR of stool * Known carriers of vancomycin-resistant enterococci (VRE) prior to study start, as determined by stool culture * Subjects with history of lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Baseline, Day, 5, 14, 35 | Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Immune Markers Assessment at Day 5, 14 and 28 | Baseline-28 days | Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels. |
| Blood Pressures of Subjects From Baseline to Day 35 | Day 0 - 35 | Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \[BP\]). Descriptive statistics performed by dose group and visit. |
| Heart Rates of Subjects From Baseline to Day 35 | Day 0-35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit. |
| Respiratory Rates of Subjects From Baseline to Day 35 | Day 0-35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit. |
| Temperatures of Subjects From Baseline to Day 35 | Day 0-35 | Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antibiotics Alone D1-D5: Antibiotics (3x daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose) | 19 |
| Antibiotics, Probiotic, HMO D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 18 g HMO concentrate (9g twice daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
HMO Concentrate: Concentrated milk fortifiers from donor human milk
Probiotic: B. infantis | 19 |
| Antibiotics, Probiotic D1-D5: Antibiotics (3x daily) D1-D14: Probiotic
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Probiotic: B. infantis | 18 |
| Antibiotics, Probiotic, HMO, Food D1-D5: Antibiotics (3x daily) D1-D14: Probiotic + 18 g HMO concentrate (9g twice daily) D15-D28: 22g Food Supplement (11 g daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
HMO Concentrate: Concentrated milk fortifiers from donor human milk
Probiotic: B. infantis
Food Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT) | 18 |
| Antibiotics, Probiotic, Food D1-D5: Antibiotics (3x daily) D1-D14: Probiotic D1-D28: 22g Food Supplement (11 g daily)
Antibiotic: Vancomycin (250 mg/dose), Metronidazole (500 mg/dose)
Probiotic: B. infantis
Food Supplement: Synthetic powder containing 2'-fucosyllactose (2'-FL) and lactoneotetraose (LNnT) | 18 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Other | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Antibiotics, Probiotic, HMO | Antibiotics, Probiotic | Antibiotics, Probiotic, HMO, Food | Antibiotics Alone | Antibiotics, Probiotic, Food | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 2 Participants | 5 Participants | 1 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 14 Participants | 16 Participants | 14 Participants | 16 Participants | 78 Participants |
| Baseline Levels of B. Infantis | 31.25 copies/ng DNA STANDARD_DEVIATION 82.27 | 27.00 copies/ng DNA STANDARD_DEVIATION 0 | 27.00 copies/ng DNA STANDARD_DEVIATION 0 | 27.00 copies/ng DNA STANDARD_DEVIATION 0 | 27.00 copies/ng DNA STANDARD_DEVIATION 0 | 27.8 copies/ng DNA STANDARD_DEVIATION 36.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 13 Participants | 14 Participants | 14 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 7 Participants | 1 Participants | 3 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 11 Participants | 10 Participants | 10 Participants | 13 Participants | 11 Participants | 55 Participants |
| Region of Enrollment United States | 19 participants | 18 participants | 18 participants | 19 participants | 18 participants | 92 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 7 Participants | 12 Participants | 10 Participants | 42 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 11 Participants | 7 Participants | 8 Participants | 50 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 4 / 19 | 4 / 19 | 6 / 18 | 7 / 18 | 2 / 18 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35)
Evaluation of HMO supporting gut colonization of B.infantis in healthy adult volunteers with microbiome disruption by antibiotics. Stool samples were taken from subjects at regular intervals and prepared for DNA extraction and microbiome analysis. Following DNA extraction, samples were analyzed using subspecies-specific qPCR analysis to evaluate B.infantis colonization and monitor overall shifts using primers that target universal 16S rRNA gene shared by bacteria by log-fold changes.
Time frame: Baseline, Day, 5, 14, 35
Population: All participants assigned to an arm and were able to provide adequate evaluable samples for DNA analysis
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics Alone | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Baseline | 27.00 copies/ng DNA | Standard Deviation 0 |
| Antibiotics Alone | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 5 | 27.00 copies/ng DNA | Standard Deviation 0 |
| Antibiotics Alone | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 14 | 28.08 copies/ng DNA | Standard Deviation 6.87 |
| Antibiotics Alone | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 35 | 27.00 copies/ng DNA | Standard Deviation 0 |
| Antibiotics, Probiotics, HMO | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Baseline | 31.25 copies/ng DNA | Standard Deviation 82.27 |
| Antibiotics, Probiotics, HMO | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 35 | 311.22 copies/ng DNA | Standard Deviation 14917.81 |
| Antibiotics, Probiotics, HMO | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 5 | 383.41 copies/ng DNA | Standard Deviation 862.67 |
| Antibiotics, Probiotics, HMO | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 14 | 26877.59 copies/ng DNA | Standard Deviation 69845.62 |
| Antibiotics Probiotics | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 35 | 77.15 copies/ng DNA | Standard Deviation 1857.25 |
| Antibiotics Probiotics | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 5 | 535.35 copies/ng DNA | Standard Deviation 708.21 |
| Antibiotics Probiotics | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 14 | 1868.09 copies/ng DNA | Standard Deviation 10150.73 |
| Antibiotics Probiotics | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Baseline | 27.00 copies/ng DNA | Standard Deviation 0 |
| Antibiotics, Probiotics, HMO, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Baseline | 27.00 copies/ng DNA | Standard Deviation 0 |
| Antibiotics, Probiotics, HMO, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 5 | 204.11 copies/ng DNA | Standard Deviation 312.05 |
| Antibiotics, Probiotics, HMO, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 35 | 88.78 copies/ng DNA | Standard Deviation 1249.73 |
| Antibiotics, Probiotics, HMO, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 14 | 21736.64 copies/ng DNA | Standard Deviation 50622.14 |
| Antibiotics, Probiotics, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 35 | 170.03 copies/ng DNA | Standard Deviation 5638.54 |
| Antibiotics, Probiotics, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 14 | 45466.96 copies/ng DNA | Standard Deviation 81975.89 |
| Antibiotics, Probiotics, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Day 5 | 431.26 copies/ng DNA | Standard Deviation 883.43 |
| Antibiotics, Probiotics, Food | Evaluation of the Changes in Microbiome Species Abundance and Diversity From Baseline Until End of Study (Day 35) | Baseline | 27.00 copies/ng DNA | Standard Deviation 0 |
Comparison: Dose Group 2 B. infantis levels compared to control group (antibiotic only) with changes over timep-value: <0.0001Mixed Models Analysis
Comparison: Dose Group 3 B. infantis levels compared to control group (antibiotic only) with changes over timep-value: <0.0001Mixed Models Analysis
Comparison: Dose Group 2 (with HMO) B. infantis levels compared to dose Group 3 (without HMO) with changes over timep-value: <0.0001Mixed Models Analysis
Secondary
Blood Pressures of Subjects From Baseline to Day 35
Clinical assessments from baseline throughout study to assess vital signs of subject safety (blood pressure \[BP\]). Descriptive statistics performed by dose group and visit.
Time frame: Day 0 - 35
Population: All participants assigned to an arm and were able to provide blood pressure data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics Alone | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Baseline | 123 mmHg | Standard Deviation 13.8 |
| Antibiotics Alone | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Day 35 | 128 mmHg | Standard Deviation 16.6 |
| Antibiotics Alone | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Baseline | 75 mmHg | Standard Deviation 5.6 |
| Antibiotics Alone | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Day 35 | 75 mmHg | Standard Deviation 7.4 |
| Antibiotics, Probiotics, HMO | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Baseline | 125 mmHg | Standard Deviation 19 |
| Antibiotics, Probiotics, HMO | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Day 35 | 74 mmHg | Standard Deviation 10 |
| Antibiotics, Probiotics, HMO | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Day 35 | 127 mmHg | Standard Deviation 17.3 |
| Antibiotics, Probiotics, HMO | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Baseline | 77 mmHg | Standard Deviation 11.7 |
| Antibiotics Probiotics | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Day 35 | 77 mmHg | Standard Deviation 12.1 |
| Antibiotics Probiotics | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Day 35 | 130 mmHg | Standard Deviation 18.7 |
| Antibiotics Probiotics | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Baseline | 76 mmHg | Standard Deviation 9.7 |
| Antibiotics Probiotics | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Baseline | 127 mmHg | Standard Deviation 15.2 |
| Antibiotics, Probiotics, HMO, Food | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Baseline | 117 mmHg | Standard Deviation 11 |
| Antibiotics, Probiotics, HMO, Food | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Day 35 | 121 mmHg | Standard Deviation 14.8 |
| Antibiotics, Probiotics, HMO, Food | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Day 35 | 73 mmHg | Standard Deviation 10 |
| Antibiotics, Probiotics, HMO, Food | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Baseline | 71 mmHg | Standard Deviation 8.5 |
| Antibiotics, Probiotics, Food | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Day 35 | 71 mmHg | Standard Deviation 10.3 |
| Antibiotics, Probiotics, Food | Blood Pressures of Subjects From Baseline to Day 35 | Diastolic Blood Pressure (mmHg) - Baseline | 73 mmHg | Standard Deviation 7.9 |
| Antibiotics, Probiotics, Food | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Day 35 | 120 mmHg | Standard Deviation 18.1 |
| Antibiotics, Probiotics, Food | Blood Pressures of Subjects From Baseline to Day 35 | Systolic Blood Pressure (mmHg) - Baseline | 121 mmHg | Standard Deviation 15.6 |
Secondary
Changes in Immune Markers Assessment at Day 5, 14 and 28
Blood samples were collected at regular intervals for serum immunological parameters (LAP-TGFB, MCP1, MIP-1) to assess metabolite levels.
Time frame: Baseline-28 days
Population: Analysis of Group 1 control vs Group 2 +HMO to assess impact of study product. Subjects who provided evaluable samples for all time points were evaluated for clinical pharmacology endpoints. DATA WERE COLLECTED FOR ONLY GROUPS 1 AND 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Day 5 | 416.6 ng/mL | Standard Deviation 214 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - Day 14 | 29.7 ng/mL | Standard Deviation 9 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Day 14 | 476.8 ng/mL | Standard Deviation 243.8 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Baseline | 385.7 ng/mL | Standard Deviation 106.9 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Day 28 | 464.3 ng/mL | Standard Deviation 250.6 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - Day 28 | 30.2 ng/mL | Standard Deviation 9.3 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Day 5 | 429 ng/mL | Standard Deviation 129.9 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - Day 5 | 34.3 ng/mL | Standard Deviation 7.7 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Day 14 | 383.6 ng/mL | Standard Deviation 226.1 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Baseline | 405.6 ng/mL | Standard Deviation 211.3 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Day 28 | 315.1 ng/mL | Standard Deviation 134.5 |
| Antibiotics Alone | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - baseline | 34.3 ng/mL | Standard Deviation 8.1 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Day 28 | 322.0 ng/mL | Standard Deviation 226.7 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - baseline | 37.6 ng/mL | Standard Deviation 9.6 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - Day 5 | 34.6 ng/mL | Standard Deviation 7.8 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - Day 14 | 34.7 ng/mL | Standard Deviation 8.1 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | LAP-TGFB - Day 28 | 32.9 ng/mL | Standard Deviation 5.9 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Baseline | 399.7 ng/mL | Standard Deviation 253.3 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Day 5 | 401.8 ng/mL | Standard Deviation 215.5 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Day 14 | 411.1 ng/mL | Standard Deviation 199.1 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Baseline | 358.2 ng/mL | Standard Deviation 228.7 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Day 5 | 391.9 ng/mL | Standard Deviation 231 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MIP - Day 14 | 361.6 ng/mL | Standard Deviation 224.2 |
| Antibiotics, Probiotics, HMO | Changes in Immune Markers Assessment at Day 5, 14 and 28 | MCP1 - Day 28 | 433.8 ng/mL | Standard Deviation 187.3 |
Secondary
Heart Rates of Subjects From Baseline to Day 35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (heart rate). Descriptive statistics performed by dose group and visit.
Time frame: Day 0-35
Population: All participants assigned to an arm and were able to provide heart rate data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics Alone | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Baseline | 66 beats per minute | Standard Deviation 10.9 |
| Antibiotics Alone | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Day 35 | 69 beats per minute | Standard Deviation 10.9 |
| Antibiotics, Probiotics, HMO | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Baseline | 66 beats per minute | Standard Deviation 8.7 |
| Antibiotics, Probiotics, HMO | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Day 35 | 72 beats per minute | Standard Deviation 16.2 |
| Antibiotics Probiotics | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Baseline | 68 beats per minute | Standard Deviation 8.1 |
| Antibiotics Probiotics | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Day 35 | 73 beats per minute | Standard Deviation 11.1 |
| Antibiotics, Probiotics, HMO, Food | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Day 35 | 66 beats per minute | Standard Deviation 11.9 |
| Antibiotics, Probiotics, HMO, Food | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Baseline | 70 beats per minute | Standard Deviation 11.9 |
| Antibiotics, Probiotics, Food | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Baseline | 71 beats per minute | Standard Deviation 7.4 |
| Antibiotics, Probiotics, Food | Heart Rates of Subjects From Baseline to Day 35 | Heart rate - Day 35 | 68 beats per minute | Standard Deviation 10.1 |
Secondary
Respiratory Rates of Subjects From Baseline to Day 35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (respiratory rate). Descriptive statistics performed by dose group and visit.
Time frame: Day 0-35
Population: All participants assigned to an arm and were able to provide respiration rates
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics Alone | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Baseline | 15 breaths per minute | Standard Deviation 1.6 |
| Antibiotics Alone | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Day 35 | 15 breaths per minute | Standard Deviation 1.1 |
| Antibiotics, Probiotics, HMO | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Baseline | 15 breaths per minute | Standard Deviation 1.1 |
| Antibiotics, Probiotics, HMO | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Day 35 | 15 breaths per minute | Standard Deviation 1.4 |
| Antibiotics Probiotics | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Baseline | 15 breaths per minute | Standard Deviation 1.2 |
| Antibiotics Probiotics | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Day 35 | 15 breaths per minute | Standard Deviation 1.7 |
| Antibiotics, Probiotics, HMO, Food | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Day 35 | 15 breaths per minute | Standard Deviation 1.1 |
| Antibiotics, Probiotics, HMO, Food | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Baseline | 15 breaths per minute | Standard Deviation 1 |
| Antibiotics, Probiotics, Food | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Baseline | 16 breaths per minute | Standard Deviation 1.2 |
| Antibiotics, Probiotics, Food | Respiratory Rates of Subjects From Baseline to Day 35 | Respirations - Day 35 | 14 breaths per minute | Standard Deviation 0.9 |
Secondary
Temperatures of Subjects From Baseline to Day 35
Clinical assessment from baseline throughout study to assess vital signs of subject safety (temperature).
Time frame: Day 0-35
Population: All participants assigned to an arm and were able to provide temperatures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Antibiotics Alone | Temperatures of Subjects From Baseline to Day 35 | Temperature - Baseline | 36.8 deg C | Standard Deviation 0.21 |
| Antibiotics Alone | Temperatures of Subjects From Baseline to Day 35 | Temperature - Day 35 | 36.9 deg C | Standard Deviation 0.14 |
| Antibiotics, Probiotics, HMO | Temperatures of Subjects From Baseline to Day 35 | Temperature - Baseline | 36.7 deg C | Standard Deviation 0.24 |
| Antibiotics, Probiotics, HMO | Temperatures of Subjects From Baseline to Day 35 | Temperature - Day 35 | 36.8 deg C | Standard Deviation 0.19 |
| Antibiotics Probiotics | Temperatures of Subjects From Baseline to Day 35 | Temperature - Baseline | 36.9 deg C | Standard Deviation 0.24 |
| Antibiotics Probiotics | Temperatures of Subjects From Baseline to Day 35 | Temperature - Day 35 | 36.8 deg C | Standard Deviation 0.13 |
| Antibiotics, Probiotics, HMO, Food | Temperatures of Subjects From Baseline to Day 35 | Temperature - Day 35 | 36.8 deg C | Standard Deviation 0.28 |
| Antibiotics, Probiotics, HMO, Food | Temperatures of Subjects From Baseline to Day 35 | Temperature - Baseline | 36.8 deg C | Standard Deviation 0.28 |
| Antibiotics, Probiotics, Food | Temperatures of Subjects From Baseline to Day 35 | Temperature - Baseline | 36.9 deg C | Standard Deviation 0.22 |
| Antibiotics, Probiotics, Food | Temperatures of Subjects From Baseline to Day 35 | Temperature - Day 35 | 36.8 deg C | Standard Deviation 0.28 |