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Low recruitment power
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A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosed Parkinson's disease | Patients with incident Parkinson's disease |
| |
| Control | Volunteers without diagnosed Parkinson's disease not meeting the exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 16S rRNA gene sequencing | Diagnostic Test | Taking a stool sample for gut microbiome DNA sequencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome composition of participants | Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample | Baseline |
| Genotypes of participants | High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample | Baseline |
| Hoehn, Yahr scale | The Hoehn and Yahr scale defining five basic stages of PD progression (0-5) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity questionnaire | 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). | Baseline |
| Food frequency questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers and patients with incident Parkinson's disease from Russia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siberian State Medical University | Tomsk | Russia |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020022 | Genetic Predisposition to Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| DNA-microarray genotyping | Genetic | Taking a saliva sample for genotyping |
|
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. |
| 12 months before baseline |
| Change in Stool consistency | The Bristol stool scale is a diagnostic medical metric designed to classify the form of human faeces into seven categories | Baseline |
| Change in Stool frequency | Change in the number of stool per week | Baseline |
| Change in Quality of Life: SF-36 questionnaire | 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 | Baseline |
| Psychological distress questionnaire | 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 |
| MOCA scale questionnaire | 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |