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NCT04263376 · ClinicalTrials.gov registry record
Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 18
- Enrollment target
NCT04263376: Completed study, sponsored by The Cleveland Clinic.
NCT04263376 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04263376 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 18 participants
- Enrollment target
Study Summary
This study is designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. The only addition to the standard of care protocol will be collection of fecal samples at 3 time points. This will enable investigators to compare changes in and effects by microbiota after low-calorie diet versus after bariatric surgery .
Primary Outcome
Test for intrapersonal longitudinal changes in human gut microbiota in patients with obesity undergoing bariatric surgery at 3 time points: baseline (preoperative), after diet-induced non-surgical weight loss, and 3-months post-operative. Metagenomic characterization of gut microbial communities will be longitudinally examined with human feces at 3 time points. Microbiota profiles will be assessed in fecal samples using V4 variable regions of the 16S rRNA gene by MiSeq 250-base paired-end multi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-04-24 |
| Est. Completion | 2022-01-31 |
What the finished NCT04263376 record still lists
NCT04263376 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 18 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04263376 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04263376 about?
NCT04263376 is a clinical study titled "Bariatric Surgery-Induced Shift in Gut Microbiome and NAFLD". This study is designed as a prospective pilot study for longitudinal assessment of fecal microbiome related to medical and surgical weight loss. The investigators follow the standard of care for perioperative and intraoperative management of study participants. The only addition to the standard of c...
What is the current status of trial NCT04263376?
This trial is currently completed. The enrollment target is 18 participants. The study started on 2019-04-24. Estimated completion is 2022-01-31.
Who is sponsoring clinical trial NCT04263376?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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