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

• ClinicalTrials.gov Identifier: NCT04119596
• Recruitment Status: Not yet recruiting
• First Posted: October 8, 2019
• Last Update Posted: October 11, 2019
• Sponsor: Atlas Biomed
• Information provided by (Responsible Party): Atlas Biomed

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Parkinson Disease; Genetic Predisposition	Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
• Estimated Study Start Date: February 1, 2020
• Estimated Primary Completion Date: February 1, 2021
• Estimated Study Completion Date: August 25, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Diagnosed Parkinson's disease; Patients with incident Parkinson's disease	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
Control; Volunteers without diagnosed Parkinson's disease not meeting the exclusion criteria	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

Outcome Measures

Primary Outcome Measures :

1. Gut microbiome composition of participants [ Time Frame: Baseline ]
   Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample
2. Genotypes of participants [ Time Frame: Baseline ]
   High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
3. Hoehn, Yahr scale [ Time Frame: Baseline ]
   The Hoehn and Yahr scale defining five basic stages of PD progression (0-5)

Secondary Outcome Measures :

1. Physical activity questionnaire [ Time Frame: Baseline ]
   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).
2. Food frequency questionnaire [ Time Frame: 12 months before baseline ]
   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.
3. Change in Stool consistency [ Time Frame: Baseline ]
   The Bristol stool scale is a diagnostic medical metric designed to classify the form of human faeces into seven categories
4. Change in Stool frequency [ Time Frame: Baseline ]
   Change in the number of stool per week
5. Change in Quality of Life: SF-36 questionnaire [ Time Frame: Baseline ]
   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
6. Psychological distress questionnaire [ Time Frame: Baseline ]

   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

7. MOCA scale questionnaire [ Time Frame: Baseline ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and patients with incident Parkinson's disease from Russia

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

Contacts and Locations

Contacts

Contact: Natalia G Zhukova, MD, PhD; +79138246202; znatali@yandex.ru

Contact: Vladimir A Romanov; +79215797830; romanov@atlas.ru

Sponsors and Collaborators

Atlas Biomed

More Information

• Responsible Party: Atlas Biomed
• ClinicalTrials.gov Identifier: NCT04119596 History of Changes
• Other Study ID Numbers: PSM
• First Posted: October 8, 2019
• Last Update Posted: October 11, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atlas Biomed:

Gut Microbiota; Parkinson's disease; Genetics; Microbiome; FFQ; GPAQ; HADS; MOCA

Additional relevant MeSH terms:

Parkinson Disease; Disease Susceptibility; Genetic Predisposition to Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes