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

NCT01662791 | Completed Phase 3 Results

• 1 other identifier: 11-006817
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Small Bowel Bacterial Overgrowth; Weight Loss; Gastrointestinal; Rifaximin

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)

  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 methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane.

  Baseline to 2 hours

Secondary Outcomes (7)

• PD-specific Quality of Life Questionnaire (PDQ-39)

  baseline

• PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group

  Baseline and 3 months

• Gastrointestinal Symptom Severity Index (GISSI)

  Baseline

• Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group

  baseline, 3 months

• Hospital Anxiety and Depression Scale (HADS)

  Baseline

Other Outcomes (1)

• Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)

  Baseline

Study Arms (2)

Case Group

EXPERIMENTAL

All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.

Drug: Rifaximin

Control Group

NO INTERVENTION

This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.

Interventions

Rifaximin DRUG

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.

Also known as: Xifaxan

Case Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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 that may 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 interfere with 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Weight Loss

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. John K. DiBaise
• Organization: Mayo Clinic

DiBaise.John@mayo.edu

480-301-6990

Study Officials

• John Di Baise, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 10, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 4, 2016
• Results First Posted: August 4, 2016

Record last verified: 2016-06

Locations

US (1)