Human Gut Microbiota and Prebiotic Response

Not Applicable

Completed

• Conditions: Healthy Gut Microbiota
• Interventions: Dietary Supplement: Prebiotic A - inulin; Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Dietary Supplement: Prebiotic C - wheat dextrin

• Registration Number: NCT03595306
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-23
• Status Verified: 2019-05
• Primary Completion: 2019-05-19
• Study Completion: 2019-05-19
• Last Update Submitted: 2019-05-31
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Provide Stool Samples at no risk to yourself

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Prebiotic A	Prebiotic B - galactooligosaccharides(GOS)	-
Prebiotic C	Prebiotic C - wheat dextrin	-
Prebiotic C	Prebiotic B - galactooligosaccharides(GOS)	-
Prebiotic C	Prebiotic A - inulin	-
Prebiotic B	Prebiotic B - galactooligosaccharides(GOS)	-
Prebiotic A	Prebiotic A - inulin	-
Prebiotic A	Prebiotic C - wheat dextrin	-
Prebiotic B	Prebiotic A - inulin	-
Prebiotic B	Prebiotic C - wheat dextrin	-

Primary Outcome Measures

Name	Time	Method
change in levels of SCFAs in stool samples	Baseline and 6 weeks

Secondary Outcome Measures

Name	Time	Method
change in levels of cytokines in stool samples	Baseline and 6 weeks

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States