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

This study is currently recruiting participants.
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
John K. DiBaise, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01662791
First received: August 7, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

The potential role of Small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with PD has not previously been examined. Our hypothesis is that SBBO is an important contributor to the development of weight loss in individuals with Parkinson's disease. The investigators propose 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 propose to perform a prospective, observational case-control study with an open-label therapeutic component. Cases will be defined as those PD patients who've experienced significant weight loss while Controls will be defined as those PD patients who have not experienced significant weight loss.


Condition Intervention Phase
Parkinson's Disease
Drug: Rifaximin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial Overgrowth

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Small bowel bacterial overgrowth (SBBO) [ Time Frame: Baseline to 2 hours ] [ Designated as safety issue: No ]
    overnight fast, will ingest a solution consisting of 50 grams of glucose mixed in 150 mL of water. laboratory staff will collect end-expiratory breath samples and will analyze them for hydrogen and methane using a Quintron SC breath microlyzer


Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    The scale consists of 4 sections that assess behavior and mood, activities of daily living, motor symptoms, and complications of therapy. The first 3 sections comprise individual items that are rated on a 5-point scale (0 [no disability] to 4 [maximum disability]), with a maximum score of 175 for these 3 sections. Higher UPDRS scores reflect more severe disease. The fourth section of the scale is used to evaluate patients with more advanced disease who are receiving drug treatment. It takes about 15 minutes to complete.

  • Gastrointestinal Symptom Severity Index (GISSI) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; and, GERD/Chest symptoms. It takes less than 5 minutes to complete.

  • Hospital Anxiety Depression Scale (HAD) [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression. It takes less than 5 minutes to complete.

  • Weight change [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Weight change after treatment

  • PD-specific quality of life questionnaire (PDQ-39) [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    questionnaire designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all.

  • Paffenbarger physical activity questionnaire (PAQ) [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    measuring 1-week physical activity


Other Outcome Measures:
  • Brief Block Food Frequency Questionnaire (FFQ) [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    assess differences in macronutrient, fiber and energy intake among the study participants. This questionnaire contains a food list of about 70 food items and takes 15-20 minutes to complete.


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin
All individuals in the weight loss group (i.e., only the Case group) will be 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 will receive antibiotic treatment.
Drug: Rifaximin
All individuals in the weight loss group (i.e., only the Case group) will be 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 will receive antibiotic treatment. The patient will be contacted by phone 1 month after treatment at which time the presence of GI symptoms will be determined and inquiry made about any adverse effects related to rifaximin use. GI symptoms, quality of life, weight measurement and breath testing will be repeated at a 3 month study visit.
Other Name: Xifaxin

Detailed Description:

Hypothesis: Small bowel bacterial overgrowth is an important contributor to the development of weight loss in individuals with Parkinson's disease.

Specific aims: 1) To determine the prevalence of SBBO in consecutive patients seen in a Parkinson's disease specialty clinic, and 2) To evaluate the effect of SBBO treatment in PD patients with weight loss.

Study design: Prospective, observational case-control study with open-label therapeutic component. Cases will be defined as those PD patients who've experienced significant weight loss while Controls will be defined as those PD patients who have not experienced significant weight loss.

Part 1:

Consecutive patients seen in the Parkinson's disease clinic at MCA will be approached to participate. After the determination of their eligibility and appropriate signed informed consent, all PD patients (i.e., both Case and Control groups) will undergo 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. Evaluation of gastrointestinal symptoms (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. HAD survey
  9. Glucose hydrogen breath test (SBBO test)
  10. Qualitative assessments of smell and taste

All questionnaires will be completed during the 2 hour breath test.

Part 2:

All individuals in the weight loss group (i.e., only the Case group) will be 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 will receive antibiotic treatment. The patient will be contacted by phone 1 month after treatment at which time the presence of GI symptoms will be determined and inquiry made about any adverse effects related to rifaximin use. GI symptoms, quality of life, weight measurement and breath testing will be repeated at a 3 month study visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01662791

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Michaele Menghini    480-301-4319      
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: John Di Baise, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: John K. DiBaise, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01662791     History of Changes
Other Study ID Numbers: 11-006817
Study First Received: August 7, 2012
Last Updated: January 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Parkinson's Disease
Small Bowel Bacterial Overgrowth

Additional relevant MeSH terms:
Parkinson Disease
Weight Loss
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Anti-Bacterial Agents
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014