Status:
TERMINATED
Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
Lead Sponsor:
Atlas Biomed
Conditions:
Parkinson Disease
Genetic Predisposition
Eligibility:
All Genders
45+ years
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 questionnai...
Eligibility Criteria
Inclusion
- Men and women aged 45 years and over who have been diagnosed with Parkinson's disease
- Subject signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 25 2022
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04119596
Start Date
September 1 2020
End Date
February 25 2022
Last Update
July 21 2022
Active Locations (1)
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1
Siberian State Medical University
Tomsk, Russia