The Microbiome in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

The Microbiome in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129451
• Other study ID #: 2016-313
• Status: Completed
• Start date: April 17, 2017
• Est. completion date: January 7, 2021

Study information

• Verified date: April 2024
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Diagnostic Test:
• Microbiome specimens in stool
Analyzing Microbiome specimens in stool

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Van Andel Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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