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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 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.

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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.

Interventions

  • DRUG Vancomycin
  • DRUG Placebo oral tablet
  • OTHER Overfeeding diet (OF)
  • OTHER Underfeeding diet (UF)

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2014-01-14
Est. Completion 2019-03-29
Phase Phase 2

What the Registry Record Tells You About NCT02037295

The ClinicalTrials.gov registry entry for NCT02037295 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Vancomycin is the first listed.

NCT02037295 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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