Intestinal Health
Conditions
Keywords
Prebiotics, Galactooligosaccharides, Lactosamine
Brief summary
This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins and human milk oligosaccharides (LAcNac, humanized GOS, hGOS) in healthy adult individuals. The safety and tolerability of the dose and the biological signature of GOS and hGOS in healthy adults will be established through a pilot clinical trial to assess GOS and hGOS effects vs placebo on (i) gastrointestinal adverse effects as measured by the Gastrointestinal Symptom and Severity Checklist (GSSC), (ii) increased abundance of beneficial gut bacteria and restoration of the gut microbiome saccharolytic potential, (iii) modulation of biomarkers of inflammation and (iv) evaluation of intestinal barrier function.
Interventions
DIETARY_SUPPLEMENT"Humanized" galacto-oligosaccharides (hGOS)
10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage
DIETARY_SUPPLEMENTGalacto-oligosaccharides (GOS)
10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.
OTHERMatching Placebo
10-15 g/day powdered corn syrup comprised of fructose, glucose, and an inert cellulose material that matches the consistency, color sweetness, and taste of the prebiotics, that can be added to any non-alcoholic beverage.
Sponsors
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
3 arms: GOS, hGOS, or placebo, with 16 participants per arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and 32. * Individuals must be able to give informed consent. * Subjects willing and able to: * consume prebiotics or placebo preparations for a period of 4 weeks. * Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire. * provide stool and blood (via venipuncture) samples. * Enrollment will not be restricted based on race, ethnicity, or gender. The subject population will reflect the population providing a broad selection of individuals to allow enrollment of subjects from all races, ethnicities, and genders, as represented in North Carolina state.
Exclusion criteria
* Less than 18 years of age or older than 55 years of age * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Composite PROMIS Maximum Scores | Between week 0 (Baseline) and week 4 | The overall Patient-Reported Outcomes Measurement Information System (PROMIS) score symptom (composite) was calculated as follows: Individual items from the GI questionnaire were grouped into seven symptom domains: abdominal pain, bloating, abdominal distension, flatulence, constipation, diarrhea, and nausea. Each item was rated on a 0-4 scale (0 = "never," 4 = "always"). For each participant at each visit (week 0 and week 4), a domain-specific symptom severity score was defined as the maximum item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in Relative Abundance of Beneficial Bacteria | Between week 0 (Baseline) and week 4 | The difference in relative abundance of beneficial bacteria of interest include Bifidobacterium and Akkermansia (pre and post intervention) as measured by whole genome sequencing of stool. |
| Interleukin-1α Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interleukin-1ß Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interleukin-6 Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interleukin-8 Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interleukin-12 Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interleukin-17 Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interleukin-18 Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Tumor Necrosis Factor Alpha (TNF-α) Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Interferon Gamma (IFNγ) Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Change in C-Reactive Protein Concentration | Between week 0 (Baseline) and week 4 | Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L. |
| Change in Zonulin Concentration | Between week 0 (Baseline) and week 4 | Used to assess modulation in intestinal barrier function in blood and reported in ng/mL. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSylvia Becker-Dreps, MD, MPH
University of North Carolina, Chapel Hill
Participant flow
Pre-assignment details
Sixty participants signed informed consent and enrolled in the study. Before the baseline visit (Week 0), 10 participants voluntarily withdrew consent, leaving 50 participants who completed the baseline assessment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex/Gender, Customized Female | 13 Participants |
| Sex/Gender, Customized Male | 8 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 1 / 17 | 0 / 17 | 3 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 16 |
Outcome results
None listed