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NCT02037295 · ClinicalTrials.gov registry record · Phase 2
Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02037295: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02037295 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02037295, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
Calculated as stool calories (kcal/day) x 100/ingested calories (kcal/day)
Interventions
- DRUG Vancomycin
- DRUG Placebo oral tablet
- OTHER Overfeeding diet (OF)
- OTHER Underfeeding diet (UF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-01-14 |
| Est. Completion | 2019-03-29 |
| Phase | Phase 2 |
What the finished NCT02037295 record still lists
NCT02037295 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Vancomycin is the first listed.
NCT02037295 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02037295 about?
NCT02037295 is a clinical study titled "Investigation of the Gut Microbiota in Regulating Nutrient Absorption in Humans". 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 ant...
What is the current status of trial NCT02037295?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2014-01-14. Estimated completion is 2019-03-29.
What interventions are being tested in trial NCT02037295?
The interventions under investigation include: Vancomycin (DRUG), Placebo oral tablet (DRUG), Overfeeding diet (OF) (OTHER), Underfeeding diet (UF) (OTHER).
Who is sponsoring clinical trial NCT02037295?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02037295's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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