The Microbiome in Parkinson's Disease

NCT03129451 | Completed

• 1 other identifier: 2016-313
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• The current study determines whether certain Parkinson's subtypes are prone to pro-inflammatory microbiomes.

  Differences in microbiome abundance will be detected using a Kruskal-Wallis' test generating a Benjamini-Hochberg false discovery rate (FDR)-corrected P value (\<0.05 for significance). For the microbiome analysis, in silico community functional predictions will be performed using PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) and significant differences in Kyoto Encyclopedia of Genes and Genomes (KEGG) ortholog (KO) abundances between groups will be identified (FDR-corrected P value \<0.05 for significance). Putative "proinflammatory" and "anti-inflammatory" bacteria taxa will be classified based on previous reports (and the references therein) (see Keshavarzian et al., 2015). Differences in inflammatory metabolite abundance will be detected using a Kruskal-Wallis' test generating a Benjamini-Hochberg false discovery rate (FDR)-corrected P value (0.05).

  3 years

Study Arms (7)

Tremor-dominant

Tremor-dominant Parkinson's disease

Diagnostic Test: Microbiome specimens in stool

Akinetic-Rigid

Akinetic-Rigid type Parkinson's disease

Diagnostic Test: Microbiome specimens in stool

Multiple systems atrophy

Multiple systems atrophy PD

Diagnostic Test: Microbiome specimens in stool

Levodopa-naïve

Levodopa-naïve Parkinson's disease

Diagnostic Test: Microbiome specimens in stool

Tremor-dominant / app

Tremor-dominant Parkinson's disease with an appendectomy

Diagnostic Test: Microbiome specimens in stool

Akinetic-Rigid / app

Akinetic-Rigid Parkinson's disease with an appendectomy

Diagnostic Test: Microbiome specimens in stool

Levodopa-naïve w/app

Levodopa-naïve Parkinson's disease with an appendectomy

Diagnostic Test: Microbiome specimens in stool

Interventions

Microbiome specimens in stool DIAGNOSTIC_TEST

Analyzing Microbiome specimens in stool

Akinetic-Rigid; Akinetic-Rigid / app; Levodopa-naïve; Levodopa-naïve w/app; Multiple systems atrophy; Tremor-dominant; Tremor-dominant / app

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will examine individuals who are current patients of a Spectrum Health Movement Disorder physician with: 1) Tremor-dominant Parkinson's disease, 2) Akinetic-Rigid type Parkinson's disease, 3) Multiple systems atrophy (MSA-P), 4) Levodopa-naïve Parkinson's disease, 5) Tremor-dominant Parkinson's disease with an appendectomy, 6) Akinetic-Rigid Parkinson's disease with an appendectomy, 7) Levodopa-naïve Parkinson's disease with an appendectomy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health West: lead
• Van Andel Research Institute: collaborator

Study Sites (1)

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Defecation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ashok Sriram, MD, MS

  Spectrum Health Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: April 17, 2017
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)