Human Gut Microbiota and Prebiotic Response

May 31, 2019 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in levels of SCFAs in stool samples
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
change in levels of cytokines in stool samples
Time Frame: Baseline and 6 weeks
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Lawrence David, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

May 19, 2019

Study Completion (Actual)

May 19, 2019

Study Registration Dates

First Submitted

July 11, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00087214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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