The Microbiome in Parkinson's Disease

NCT ID: NCT03129451

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2021-01-07

Brief Summary

To investigate the dynamic relationship between the intestinal microbiota and Inflammation in subjects with Parkinson's disease.

Detailed Description

To investigate the dynamic relationship between the intestinal microbiota and Inflammation in subjects with Parkinson's disease. The current study examines the differential microbiome of the gut in subjects with parkinsonism. The current study determines whether certain Parkinson's subtypes are prone to pro-inflammatory microbiomes. This study also explores whether the intestinal microbiome in post-appendectomy Parkinson's subjects is modified as appendix has a role in regulating intestinal microbiome. The current study will examine whether microbiome changes influence inflammatory markers in the blood.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Tremor-dominant

Tremor-dominant Parkinson's disease

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Akinetic-Rigid

Akinetic-Rigid type Parkinson's disease

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Multiple systems atrophy

Multiple systems atrophy PD

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Levodopa-naïve

Levodopa-naïve Parkinson's disease

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Tremor-dominant / app

Tremor-dominant Parkinson's disease with an appendectomy

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Akinetic-Rigid / app

Akinetic-Rigid Parkinson's disease with an appendectomy

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Levodopa-naïve w/app

Levodopa-naïve Parkinson's disease with an appendectomy

Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Interventions

Microbiome specimens in stool

Analyzing Microbiome specimens in stool

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Individuals with Parkinson's disease (including multiple system atrophy). Males and females are eligible for the study. Appendectomized cohort must have had their appendectomy at least 20 years before Parkinson's disease onset

Exclusion Criteria

• 1. Body Mass Index greater than or equal to 35 or less than or equal to 18. 2. Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure >160/100, oral temperature >100°F, pulse >100.

3. Use of any of the following drugs within the last 6 months:

• systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
• cytokines;
• methotrexate or immunosuppressive cytotoxic agents;
• large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.

4. Acute viral/bacterial infection disease at the time of sampling (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.

5. Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.

6. Recent history of chronic alcohol consumption defined as more than five 1.5- ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.

7. Positive test for HIV, HBV or HCV. 8. Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.

9. Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.

10. History of active uncontrolled gastrointestinal disorders or diseases including:

• inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
• irritable bowel syndrome (IBS) (moderate-severe);
• persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated); 11. Female who is pregnant or lactating. 12. Atypical or secondary Parkinson's disease 13. Adults that are unable to consent, individuals that are not yet adults and prisoners are not eligible for this study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Van Andel Research Institute

OTHER

Sponsor Role: collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Ashok Sriram

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashok Sriram, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Medical Group

Locations

Spectrum Health

Grand Rapids, Michigan, United States

Countries

United States

Other Identifiers

2016-313

Identifier Type: -

Identifier Source: org_study_id