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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04119596
Other study ID # PSM
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date February 25, 2022

Study information

Verified date February 2020
Source Atlas Biomed
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 138
Est. completion date February 25, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
16S rRNA gene sequencing
Taking a stool sample for gut microbiome DNA sequencing
Genetic:
DNA-microarray genotyping
Taking a saliva sample for genotyping

Locations

Country Name City State
Russian Federation Siberian State Medical University Tomsk

Sponsors (1)

Lead Sponsor Collaborator
Atlas Biomed

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gut microbiome composition of participants Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample Baseline
Primary Genotypes of participants High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample Baseline
Primary Hoehn, Yahr scale The Hoehn and Yahr scale defining five basic stages of PD progression (0-5) Baseline
Secondary 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
Secondary Food frequency questionnaire 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
Secondary 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
Secondary Change in Stool frequency Change in the number of stool per week Baseline
Secondary 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
Secondary 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
Secondary 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
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