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

  • Study type:

    Interventional What is this?

    Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

Study IDs

  • Site IRB:

    • Scottsdale/Phoenix, Arizona: 11-006817
  • NCT ID:

    NCT01662791
  • Sponsor Protocol Number:

    11-006817

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion criteria:

  1. 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

John DiBaise, M.D.

Closed for enrollment

Michaele Menghini

(480)301-6651

Menghini.Michaele@mayo.edu