Human Gut Microbiota and Prebiotic Response

NCT ID: NCT03595306

Last Updated: 2019-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-05-19

Brief Summary

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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

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Conditions

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Healthy Gut Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Prebiotic A

Group Type EXPERIMENTAL

Prebiotic A - inulin

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic B - galactooligosaccharides(GOS)

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic C - wheat dextrin

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic B

Group Type EXPERIMENTAL

Prebiotic A - inulin

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic B - galactooligosaccharides(GOS)

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic C - wheat dextrin

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic C

Group Type EXPERIMENTAL

Prebiotic A - inulin

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic B - galactooligosaccharides(GOS)

Intervention Type DIETARY_SUPPLEMENT

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

Prebiotic C - wheat dextrin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Prebiotic A - inulin

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

Intervention Type DIETARY_SUPPLEMENT

Prebiotic B - galactooligosaccharides(GOS)

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

Intervention Type DIETARY_SUPPLEMENT

Prebiotic C - wheat dextrin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence David

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00087214

Identifier Type: -

Identifier Source: org_study_id

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