Clinical trial NCT03129451: The Microbiome in Parkinson's Disease
Official title: The Microbiome in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Van Andel Research Institute
First posted: 2017-04-26
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: The current study determines whether certain Parkinson's subtypes are prone to pro-inflammatory microbiomes.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Spectrum Health Medical Group
name: Ashok Sriram, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: