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The Microbiome in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03129451
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Van Andel Research Institute
Information provided by (Responsible Party):
Casey Michael Doyle, Spectrum Health Hospitals

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

Condition or disease Intervention/treatment
Parkinson Disease Diagnostic Test: Microbiome specimens in stool

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.

Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Microbiome in Parkinson's Disease
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tremor-dominant
Tremor-dominant Parkinson's disease
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Akinetic-Rigid
Akinetic-Rigid type Parkinson's disease
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Multiple systems atrophy
Multiple systems atrophy PD
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Levodopa-naïve
Levodopa-naïve Parkinson's disease
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Tremor-dominant / app
Tremor-dominant Parkinson's disease with an appendectomy
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Akinetic-Rigid / app
Akinetic-Rigid Parkinson's disease with an appendectomy
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Levodopa-naïve w/app
Levodopa-naïve Parkinson's disease with an appendectomy
Diagnostic Test: Microbiome specimens in stool
Analyzing Microbiome specimens in stool




Primary Outcome Measures :
  1. The current study determines whether certain Parkinson's subtypes are prone to pro-inflammatory microbiomes. [ Time Frame: 3 years ]
    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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will examine individuals 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
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129451


Contacts
Contact: Ashok Sriram 616-267-7900 ashok.sriram@spectrumhealth.org
Contact: Casey Doyle 616-486-6128 casey.doyle@spectrumhealth.org

Locations
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Casey Doyle    616-486-6128    casey.doyle@spectrumhealth.org   
Principal Investigator: Ashok Sriram         
Sponsors and Collaborators
Spectrum Health Hospitals
Van Andel Research Institute

Responsible Party: Casey Michael Doyle, CRC, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT03129451     History of Changes
Other Study ID Numbers: Parkinson's Microbiome
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs