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Human Gut Microbiota and Prebiotic Response

Human Gut Microbiota and Prebiotic Response

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03595306
Enrollment
41
Registered
2018-07-23
Start date
2018-05-01
Completion date
2019-05-19
Last updated
2019-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Gut Microbiota

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.

Interventions

DIETARY_SUPPLEMENTPrebiotic A - inulin

Pre-weighed packages will be given twice daily for 5 days.

DIETARY_SUPPLEMENTPrebiotic B - galactooligosaccharides(GOS)

Pre-weighed packages will be given twice daily for 5 days.

DIETARY_SUPPLEMENTPrebiotic C - wheat dextrin

Pre-weighed packages will be given twice daily for 5 days.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
17 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frame
change in levels of SCFAs in stool samplesBaseline and 6 weeks

Secondary

MeasureTime frame
change in levels of cytokines in stool samplesBaseline and 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026