Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease

NCT04119596 | Terminated DMC

• 1 other identifier: PSM
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease.

Conditions

Parkinson Disease; Genetic Predisposition

Keywords

Gut Microbiota; Parkinson's disease; Genetics; Microbiome; FFQ; GPAQ; HADS; MOCA

Outcome Measures

Primary Outcomes (3)

• Gut microbiome composition of participants

  Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample

  Baseline

• Genotypes of participants

  High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample

  Baseline

• Hoehn, Yahr scale

  The Hoehn and Yahr scale defining five basic stages of PD progression (0-5)

  Baseline

Secondary Outcomes (7)

• Physical activity questionnaire

  Baseline

• Food frequency questionnaire

  12 months before baseline

• Change in Stool consistency

  Baseline

• Change in Stool frequency

  Baseline

• Change in Quality of Life: SF-36 questionnaire

  Baseline

Study Arms (2)

Diagnosed Parkinson's disease

Patients with incident Parkinson's disease

Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping

Control

Volunteers without diagnosed Parkinson's disease not meeting the exclusion criteria

Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping

Interventions

16S rRNA gene sequencing DIAGNOSTIC_TEST

Taking a stool sample for gut microbiome DNA sequencing

Control; Diagnosed Parkinson's disease

DNA-microarray genotyping GENETIC

Taking a saliva sample for genotyping

Control; Diagnosed Parkinson's disease

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with incident Parkinson's disease from Russia

You may qualify if:

• Men and women aged 45 years and over who have been diagnosed with Parkinson's disease
• Subject signed informed consent

You may not qualify if:

• Gastroenterological diseases such as ulcerative colitis, Crohn's disease, celiac disease, gallbladder diseases (calculous cholecystitis, cholangitis, etc.) that are not related to functional disorders, a liver diseases or pancreas in medical history
• Exacerbations of chronic gastroenterological diseases
• Mental illness
• Oncology diseases
• Mental disorders
• Rheumatoid arthritis or other autoimmune diseases
• Acute infectious diseases or exacerbation of any diseases
• Recent (\<3 months) administration of proton pump inhibitors, antimicrobial therapy or surgical intervention
• Recent (\<3 weeks) use of probiotics, antacids, nonsteroidal anti-inflammatory drugs, laxatives
• Recent (\<14 days) administration of laxatives (excluding prucaloprid)
• Recent (\< 3 months) surgical intervention
• Pregnancy, planning to be pregnant or breast feeding at any point during the study or study enrollment
• Current alcohol/drug abuse (more than 3 points for women and 4 for men according to AUDIT-C questionnaire and/or more than 7 points on the AUDIT questionnaire) or addiction therapy within 12 months prior to screening
• Planned relocation from the home region during the study
• Stroke in medical history

Sponsors & Collaborators

• Atlas Biomed: lead

Study Sites (1)

Siberian State Medical University

Tomsk, Russia

Location

MeSH Terms

Conditions

Parkinson Disease; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: September 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 25, 2022
• Last Updated: July 21, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)