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NCT01662791 · ClinicalTrials.gov registry record · Phase 3
Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT01662791: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT01662791 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01662791, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was that SBBO is an important contributor to the development of weight loss in individuals with PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in patients with PD and 2) determine the response to its treatment with a poorly absorbed antibiotic. The investigators performed a prospective, observational case-control study (Part 1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients who experienced significant weight loss while Controls were defined as those PD patients who did not experience significant weight loss.
Primary Outcome
SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and met
Interventions
- DRUG Rifaximin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01662791 record still lists
NCT01662791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Rifaximin is the first listed.
NCT01662791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01662791 about?
NCT01662791 is a clinical study titled "Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth". The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was that SBBO is an important contributor to the development of weight loss in individuals with PD. The investigators prop...
What is the current status of trial NCT01662791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2012-09. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01662791?
The interventions under investigation include: Rifaximin (DRUG).
Who is sponsoring clinical trial NCT01662791?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01662791's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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