Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 1:53 AM
Study NCT ID:
NCT06068894
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2023-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2025-12-11'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 arms: GOS, hGOS, or placebo, with 16 participants per arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean GSSC Scores', 'timeFrame': 'Baseline, Week 4', 'description': 'Safe and tolerable dose of hGOS and GOS in healthy adult individuals will be measured using the Gastrointestinal Symptom and Severity Checklist (GSSC) score. The GSSC is a 38-item interviewer-administered structured questionnaire designed to assess symptoms of gastrointestinal symptoms with scores ranging from 0 to 114, with higher scores indicating more gastrointestinal symptoms.'}], 'secondaryOutcomes': [{'measure': 'Difference in Percent Abundance of Beneficial Bacteria', 'timeFrame': 'Baseline, Week 4', 'description': 'The abundance of beneficial bacteria of interest include Bifidobacterium and Akkermansia as measured by whole genome sequencing of stool.'}, {'measure': 'Change in Interleukin-1α Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Interleukin-1ß Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Interleukin-2 Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Interleukin-6 Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Interleukin-8 Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Interleukin-12 Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in Interferon gamma (IFNγ) Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured by the MCYTOMAG-70K (Milliplex) reported in pg/mL.'}, {'measure': 'Change in C-Reactive Protein Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Modulation of inflammatory biomarker as measured in blood by commercial enzyme-linked immunosorbent assay (ELISA) kit reported in mg/L.'}, {'measure': 'Change in Zonulin Concentration', 'timeFrame': 'Baseline, Week 4', 'description': 'Used to assess modulation in intestinal barrier function in blood and reported in ng/mL.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prebiotics', 'Galactooligosaccharides', 'Lactosamine'], 'conditions': ['Intestinal Health']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and 32.\n* Individuals must be able to give informed consent.\n* Subjects willing and able to:\n\n * consume prebiotics or placebo preparations for a period of 4 weeks.\n * Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire.\n * provide stool and blood (via venipuncture) samples.\n* 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.\n\nExclusion Criteria:\n\n* Less than 18 years of age or older than 55 years of age\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06068894', 'briefTitle': 'Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults', 'orgStudyIdInfo': {'id': '21-2453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS)', 'description': '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.', 'interventionNames': ['Dietary Supplement: "Humanized" galacto-oligosaccharides (hGOS)']}, {'type': 'EXPERIMENTAL', 'label': 'galacto-oligosaccharides (GOS)', 'description': '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.', 'interventionNames': ['Dietary Supplement: Galacto-oligosaccharides (GOS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '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.', 'interventionNames': ['Other: Matching Placebo']}], 'interventions': [{'name': '"Humanized" galacto-oligosaccharides (hGOS)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['hGOS'], 'description': '10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage', 'armGroupLabels': ['lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS)']}, {'name': 'Galacto-oligosaccharides (GOS)', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['GOS'], 'description': '10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage.', 'armGroupLabels': ['galacto-oligosaccharides (GOS)']}, {'name': 'Matching Placebo', 'type': 'OTHER', 'otherNames': ['Sugar powder'], 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC-Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Sylvia Becker-Dreps, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'timeFrame': 'beginning 9 and continuing for 36 months following publication', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Translational and Clinical Sciences Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}