CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 49 enrolled
Drug / intervention
Rifaximindrug
Likely dose
Rifaximin 550 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01662791
NCT01662791Phase 3Completed

Weight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial Overgrowth

Mayo Clinic·interventional·Posted Aug 10, 2012·Updated Aug 4, 2016

In Brief

A Phase 3 clinical trial evaluating Rifaximin for Parkinson's Disease. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2012
Enrollment StartSep 1, 2012
Primary CompletionJan 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.9 years ago

Interventions

Rifaximindrug

All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment will not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment.