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

NCT ID: NCT04119596

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-02-25

Brief Summary

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

Detailed Description

Two groups of subjects - one including healthy individuals and the other - treatment-naive patients with incident Parkinson's disease - will fill in the food frequency questionnaire, SF-36 questionnaire, HADS questionnaire and the physical activity questionnaire. All subjects must have 0-3 points on Hoehn and Yahr scale and more than 22 points on MoCA scale. DNA microarray genotyping will be used to process the DNA samples of the participants. The data on the composition of the participants' gut microbiota will be obtained through 16S rRNA sequencing of their stool samples.

Conditions

Parkinson Disease; Genetic Predisposition

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Diagnosed Parkinson's disease

Patients with incident Parkinson's disease

16S rRNA gene sequencing

Intervention Type: DIAGNOSTIC_TEST

Taking a stool sample for gut microbiome DNA sequencing

DNA-microarray genotyping

Intervention Type: GENETIC

Taking a saliva sample for genotyping

Control

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

16S rRNA gene sequencing

Intervention Type: DIAGNOSTIC_TEST

Taking a stool sample for gut microbiome DNA sequencing

DNA-microarray genotyping

Intervention Type: GENETIC

Taking a saliva sample for genotyping

Interventions

16S rRNA gene sequencing

Taking a stool sample for gut microbiome DNA sequencing

Intervention Type: DIAGNOSTIC_TEST

DNA-microarray genotyping

Taking a saliva sample for genotyping

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• Any surgical intervention in the central nervous system
• Morbid obesity, BMI> 35 kg / m2
• A medical history of carriage or disease associated with a history of human immunodeficiency viruses, hepatitis B, C or Treponema pallidum
• The patient's inability to understand the essence of the study and agree to participate in it. MoCA scores <22
• 4-5 stage of the disease according to the Hen and Yara scale
• Severe somatic pathologies or any factors that, in the opinion of the doctor, may prevent the patient from being included in the study
• A medical history of serious head injuries
• Rheumatoid arthritis
• Tuberculosis

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlas Biomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Siberian State Medical University

Tomsk, , Russia

Countries

Russia

Other Identifiers

PSM

Identifier Type: -

Identifier Source: org_study_id