- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119596
Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tomsk, Russian Federation
- Siberian State Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diagnosed Parkinson's disease
Patients with incident Parkinson's disease
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Taking a stool sample for gut microbiome DNA sequencing
Taking a saliva sample for genotyping
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Control
Volunteers without diagnosed Parkinson's disease not meeting the exclusion criteria
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Taking a stool sample for gut microbiome DNA sequencing
Taking a saliva sample for genotyping
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gut microbiome composition of participants
Time Frame: Baseline
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Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample
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Baseline
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Genotypes of participants
Time Frame: Baseline
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High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
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Baseline
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Hoehn, Yahr scale
Time Frame: Baseline
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The Hoehn and Yahr scale defining five basic stages of PD progression (0-5)
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity questionnaire
Time Frame: Baseline
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Physical Activity Questionnaire - information on physical activity comprising 16 questions grouped in four domains: activity at work (1), travel to and from places (2), recreational activities (3), sedentary behaviour (4).
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Baseline
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Food frequency questionnaire
Time Frame: 12 months before baseline
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Food frequency questionnaire assesses usual intake and portion size of more than 130 foods and beverages and more than 25 dietary supplements for the last 12 months.
Responses are evaluated and analyzed to assess a dietary pattern for each group of subjects.
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12 months before baseline
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Change in Stool consistency
Time Frame: Baseline
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The Bristol stool scale is a diagnostic medical metric designed to classify the form of human faeces into seven categories
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Baseline
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Change in Stool frequency
Time Frame: Baseline
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Change in the number of stool per week
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Baseline
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Change in Quality of Life: SF-36 questionnaire
Time Frame: Baseline
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According to SF-36 questionnaire The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) It is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items).
In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively
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Baseline
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Psychological distress questionnaire
Time Frame: Baseline
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Hospital Anxiety and Depression Scale (HADS) The aim of this study is to measure patients anxiety and depression, using the HADS : Hospital Anxiety and Depression scale. Scores of the HADS scale can be defined as: By adding the points of the answers: 1, 3, 5, 7, 9, 11, 13: we obtain the "Total A" which corresponds to the measure of the anxiety, then: 7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. By adding the points of the answers: 2, 4, 6, 8, 10, 12, 14: we obtain the "Total B" which corresponds to the measure of the depression, then: 7 or less: absence of symptomatology; 8 to 10: doubtful symptomatology; 11 and above: certain symptomatology. The minimal score is 0 and the maximal total score is 42 |
Baseline
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MOCA scale questionnaire
Time Frame: Baseline
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The MoCA assesses several cognitive domains: The short-term memory recall task (5 points) involves two learning trials of five nouns and delayed recall after approximately five minutes. Visuospatial abilities are assessed using a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration, and working memory are evaluated using a sustained attention task (target detection using tapping; 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). Language is assessed using a three-item confrontation naming task with low-familiarity animals (lion, camel, rhinoceros; 3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task. |
Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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