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Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans

NCT02037295 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-07-31

Study results available
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Summary

We propose to study both stool and urine energy loss in 24 individuals on two experimental diets (50% increased and 50% reduced nutrient load relative to body size) in a random cross-over design. Following this over/underfeeding, volunteers will also be randomly assigned to a placebo versus oral antibiotic medication arm. This study will extend our previous findings by investigating whether 1) nutrient absorption changes upon similar increases/decreases in relative nutrient load and 2) whether manipulation of gut microbial communities with antibiotics alters nutrient absorption and 3) how these changes may affect glucose tolerance and fat storage.

Conditions

Interventions

DRUG

Vancomycin

Vancomycin 125mg orally four times per day for 12 days

DRUG

Placebo oral tablet

Placebo pills orally four times per day for 12 days

OTHER

Overfeeding diet (OF)

Diet in which the calories are 150% of their weight maintaining energy requirements

OTHER

Underfeeding diet (UF)

Diet in which the calories are 50% of their weight maintaining energy requirements

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Jonathan Krakoff, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-14
Primary Completion
2019-03-29
Completion
2019-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037295 on ClinicalTrials.gov