Clinical trial NCT01662791: Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Official title: Weight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial Overgrowth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Small Bowel Bacterial Overgrowth
Weight Loss
Gastrointestinal
Rifaximin
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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:

1. Assessment of demographic features, weight history and PD history
2. PD and other medications
3. Determination of PD severity using the Unified Parkinson's Disease rating scale
4. Gastrointestinal Symptom Severity Index (GISSI) and modified GISSI.
5. Determination of usual calorie and nutrient intake (Brief Block Food Frequency Questionnaire)
6. Paffenbarger physical activity questionnaire
7. Quality of life (SF12 and PD-specific)
8. Hospital Anxiety and Depression Scale
9. Glucose hydrogen breath test (SBBO test)
10. 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.

Eligibility criteria: Inclusion criteria: Parkinson's Disease

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)
timeFrame: Baseline to 2 hours
Secondary outcomes:
measure: PD-specific Quality of Life Questionnaire (PDQ-39)
timeFrame: baseline
measure: PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
timeFrame: Baseline and 3 months
measure: Gastrointestinal Symptom Severity Index (GISSI)
timeFrame: Baseline
measure: Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
timeFrame: baseline, 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Weight Change in Case Group After Treatment
timeFrame: baseline, 3 months
measure: Paffenbarger Physical Activity Questionnaire (PPAQ)
timeFrame: Baseline
Other outcomes:
measure: Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
timeFrame: Baseline
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: John Di Baise, MD
role: PRINCIPAL_INVESTIGATOR
References: