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

Atlas Biomed

Status

Terminated

Conditions

Genetic Predisposition

Parkinson Disease

Treatments

Genetic: DNA-microarray genotyping

Diagnostic Test: 16S rRNA gene sequencing

Study type

Observational

Funder types

Industry

Identifiers

NCT04119596

PSM

Details and patient eligibility

About

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

Full 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.

Enrollment

138 patients

Sex

All

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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