Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04119596
• Other study ID #: PSM
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Parkinson Disease

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