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

Phase

Condition

Weight Loss

Diabetes Prevention

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT01662791

11-006817

Ages > 18
All Genders

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

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.

Eligibility Criteria

Inclusion

Inclusion criteria: Parkinson's Disease

Exclusion

Exclusion Criteria:

Wheelchair-bound, akinetic individuals
Tube-fed individuals
Presence of dementia
Unwilling or unable to complete the tests
Allergic or intolerant to rifaximin
Presence of chronic upper or lower gastrointestinal disorders that have symptoms thatmay be confused with SBBO (e.g., irritable bowel syndrome, inflammatory bowel disease,celiac disease, functional dyspepsia, gastroparesis, and chronic pancreatitis)
Presence of prior surgery on the gastrointestinal tract except cholecystectomy,appendectomy or herniorrhaphy
Presence of severe concomitant acute or chronic medical condition that may interferewith the completion or interpretation of the test results
Women of childbearing potential. Given the age of patients with Parkinson's disease,we do not anticipate this being a large population.
Use of antibiotics within 1 month of breath testing

Study Design

September 01, 2012

March 31, 2015

Study Description

Part 1:

Consecutive patients seen in the Parkinson's disease clinic at Mayo Clinic in Arizona were approached to participate. After the determination of their eligibility and appropriate signed informed consent, all PD patients (i.e., both Case and Control groups) underwent the following:

Assessment of demographic features, weight history and PD history
PD and other medications
Determination of PD severity using the Unified Parkinson's Disease rating scale
Gastrointestinal Symptom Severity Index (GISSI) and modified GISSI.
Determination of usual calorie and nutrient intake (Brief Block Food Frequency Questionnaire)
Paffenbarger physical activity questionnaire
Quality of life (SF12 and PD-specific)
Hospital Anxiety and Depression Scale
Glucose hydrogen breath test (SBBO test)
Qualitative assessments of smell and taste

All questionnaires were completed during the 2 hour breath test.

Part 2:

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 twice a day for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects could have received antibiotic treatment. The patient was contacted by phone 1 month after treatment at which time the presence of GI symptoms was determined and inquiry made about any adverse effects related to rifaximin use. GI symptoms, quality of life, weight measurement, and breath testing were repeated at a 3 month study visit.

Connect with a study center

Mayo Clinic in Arizona
Scottsdale, Arizona 85259
United States
Site Not Available

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