At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
In Brief
A Phase 2 clinical trial evaluating Vancomycin, Placebo oral tablet, and 2 other interventions for Obesity. Completed, enrolled 27 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Vancomycin 125mg orally four times per day for 12 days
Placebo pills orally four times per day for 12 days
Diet in which the calories are 150% of their weight maintaining energy requirements
Diet in which the calories are 50% of their weight maintaining energy requirements