Human Gut Microbiota and Prebiotic Response

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03595306
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.

Condition or Disease	Intervention/Treatment	Phase
Healthy Gut Microbiota	Dietary Supplement: Prebiotic A - inulin; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Dietary Supplement: Prebiotic C - wheat dextrin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Human Gut Microbiota and Prebiotic Response
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: May 19, 2019
• Actual Study Completion Date: May 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prebiotic A	Dietary Supplement: Prebiotic A - inulin; Pre-weighed packages will be given twice daily for 5 days.; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Pre-weighed packages will be given twice daily for 5 days.; Dietary Supplement: Prebiotic C - wheat dextrin; Pre-weighed packages will be given twice daily for 5 days.
Experimental: Prebiotic B	Dietary Supplement: Prebiotic A - inulin; Pre-weighed packages will be given twice daily for 5 days.; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Pre-weighed packages will be given twice daily for 5 days.; Dietary Supplement: Prebiotic C - wheat dextrin; Pre-weighed packages will be given twice daily for 5 days.
Experimental: Prebiotic C	Dietary Supplement: Prebiotic A - inulin; Pre-weighed packages will be given twice daily for 5 days.; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Pre-weighed packages will be given twice daily for 5 days.; Dietary Supplement: Prebiotic C - wheat dextrin; Pre-weighed packages will be given twice daily for 5 days.

Outcome Measures

Primary Outcome Measures

1. change in levels of SCFAs in stool samples [Baseline and 6 weeks]

Secondary Outcome Measures

1. change in levels of cytokines in stool samples [Baseline and 6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Provide Stool Samples at no risk to yourself

Exclusion Criteria:

• No oral antibiotic treatments within previous 1 month

• No known allergy to milk products or lactose intolerance

• no known allergy to wheat or gluten intolerance

• no history of irritable bowel syndrome

• no history of inflammatory bowel disease

• no history of type-2 diabetes

• no history of chronic kidney disease or reduced kidney function

• no current intestinal obstructions

• no current untreated colorectal cancer

• not currently pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27708

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Lawrence David, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03595306
• Other Study ID Numbers: Pro00087214
• First Posted: Jul 23, 2018
• Last Update Posted: Jun 3, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 3, 2019