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OpenTrials
Completed

NCT Number: NCT03595306

Human Gut Microbiota and Prebiotic Response

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.

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Key information

Conditions

Healthy Gut Microbiota

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prebiotic A - inulin

Dietary Supplement

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

Prebiotic B - galactooligosaccharides(GOS)

Dietary Supplement

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

Prebiotic C - wheat dextrin

Dietary Supplement

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

Primary outcomes

  1. change in levels of SCFAs in stool samples

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. change in levels of cytokines in stool samples

    Time frame: Baseline and 6 weeks

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.