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| Name | Class |
|---|---|
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS) | Experimental | The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. |
|
| galacto-oligosaccharides (GOS) | Experimental | The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. |
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| Placebo | Placebo Comparator | The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Humanized" galacto-oligosaccharides (hGOS) | Dietary Supplement | 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Composite PROMIS Maximum Scores | 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. | Between week 0 (Baseline) and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Relative Abundance of Beneficial Bacteria | 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. | Between week 0 (Baseline) and week 4 |
| Interleukin-1α Concentration |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Becker-Dreps, MD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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beginning 9 and continuing for 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS) | The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. "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. |
| FG001 | Galacto-oligosaccharides (GOS) | The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. Galacto-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. |
| FG002 | Placebo | The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. Matching 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS) | The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. "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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Composite PROMIS Maximum Scores | 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. | Posted | Mean | Standard Deviation | score on a scale | Between week 0 (Baseline) and week 4 |
|
From Baseline (Week 0) and continued until Week 5, up to a total of 5 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS) | The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. "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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvia Becker-Dreps, MD, MPH | University of North Carolina at Chapel Hill | 984-974-4662 | sbd@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2024 | Dec 3, 2025 | Prot_SAP_000.pdf |
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3 arms: GOS, hGOS, or placebo, with 16 participants per arm.
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| Galacto-oligosaccharides (GOS) | Dietary Supplement | 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. |
|
|
| Matching Placebo | Other | 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. |
|
|
Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. |
| Between week 0 (Baseline) and week 4 |
| Interleukin-1ß Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Interleukin-6 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Interleukin-8 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Interleukin-12 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Interleukin-17 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Interleukin-18 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Tumor Necrosis Factor Alpha (TNF-α) Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Interferon Gamma (IFNγ) Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Between week 0 (Baseline) and week 4 |
| Change in C-Reactive Protein Concentration | Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L. | Between week 0 (Baseline) and week 4 |
| Change in Zonulin Concentration | Used to assess modulation in intestinal barrier function in blood and reported in ng/mL. | Between week 0 (Baseline) and week 4 |
| BG001 | Galacto-oligosaccharides (GOS) | The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. Galacto-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. |
| BG002 | Placebo | The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. Matching 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Lactosamine-enriched "Humanized" Galacto-oligosaccharides (hGOS) |
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. "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. |
| OG001 | Galacto-oligosaccharides (GOS) | The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. Galacto-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. |
| OG002 | Placebo | The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. Matching 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. |
|
|
| Secondary | Mean Percent Change in Relative Abundance of Beneficial Bacteria | 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. | Posted | Mean | Standard Deviation | percent change | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Interleukin-1α Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Interleukin-1ß Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Interleukin-6 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Interleukin-8 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Interleukin-12 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
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|
| Secondary | Interleukin-17 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
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| Secondary | Interleukin-18 Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Tumor Necrosis Factor Alpha (TNF-α) Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| Secondary | Interferon Gamma (IFNγ) Concentration | Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL. | Posted | Mean | Standard Deviation | pg/mL | Between week 0 (Baseline) and week 4 |
|
|
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| Secondary | Change in C-Reactive Protein Concentration | Modulation of inflammatory biomarker as measured in serum by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L. | Posted | Mean | Standard Deviation | mg/L | Between week 0 (Baseline) and week 4 |
|
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| Secondary | Change in Zonulin Concentration | Used to assess modulation in intestinal barrier function in blood and reported in ng/mL. | Posted | Mean | Standard Deviation | ng/mL | Between week 0 (Baseline) and week 4 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Galacto-oligosaccharides (GOS) | The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks. Galacto-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. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Placebo | The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks. Matching 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. | 0 | 16 | 0 | 16 | 3 | 16 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| Bifidobacterium bifidum |
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| Bifidobacterium adolescentis |
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| Bifidobacterium pseudocatenulatum |
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| Bifidobacterium dentium |
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| Bifidobacterium catenulatum |
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| Bifidobacterium pseudolongum |
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| Akkermansia muciniphila |
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