Clinical trial NCT04119596: Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
Official title: Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Genetic Predisposition
Keywords: Gut Microbiota
Parkinson's disease
Genetics
Microbiome
FFQ
GPAQ
HADS
MOCA
Lead sponsor: Atlas Biomed
Sponsor class: INDUSTRY
First posted: 2019-10-08
Enrollment: 138
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and patients with incident Parkinson's disease from Russia

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.

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

Primary outcomes:
measure: Gut microbiome composition of participants
timeFrame: Baseline
measure: Genotypes of participants
timeFrame: Baseline
measure: Hoehn, Yahr scale
timeFrame: Baseline
Secondary outcomes:
measure: Physical activity questionnaire
timeFrame: Baseline
measure: Food frequency questionnaire
timeFrame: 12 months before baseline
measure: Change in Stool consistency
timeFrame: Baseline
measure: Change in Stool frequency
timeFrame: Baseline
measure: Change in Quality of Life: SF-36 questionnaire
timeFrame: Baseline
measure: Psychological distress questionnaire
timeFrame: Baseline
measure: MOCA scale questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
Study officials:
References: