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Clinical Trials/NCT03595306
NCT03595306
Completed
Not Applicable

Human Gut Microbiota and Prebiotic Response

Duke University1 site in 1 country41 target enrollmentMay 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Gut Microbiota
Sponsor
Duke University
Enrollment
41
Locations
1
Primary Endpoint
change in levels of SCFAs in stool samples
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
May 19, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

change in levels of SCFAs in stool samples

Time Frame: Baseline and 6 weeks

Secondary Outcomes

  • change in levels of cytokines in stool samples(Baseline and 6 weeks)

Study Sites (1)

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