Parkinson DiseaseNCT04119596
Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
An observational study of Parkinson Disease and Genetic Predisposition, run by Atlas Biomed at 1 site in Russia.
Trial summary
A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Genetic Predisposition
- What is being tested?
- 16S rRNA gene sequencing and DNA-microarray genotyping
- How many people
- 138 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2020to 25 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients with incident Parkinson's disease from Russia
Who may be able to join
- Men and women aged 45 years and over who have been diagnosed with Parkinson's disease
- Subject signed informed consent
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease.
Read the 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.
- Conditions
- Parkinson Disease, Genetic Predisposition
- Being tested
- 16S rRNA gene sequencing, DNA-microarray genotyping
- Keywords
- Gut Microbiota, Parkinson's disease, Genetics, Microbiome, FFQ, GPAQ, HADS, MOCA
- Medical subject headings
- Parkinson Disease, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA gene sequencingDiagnostic test
Taking a stool sample for gut microbiome DNA sequencing
DNA-microarray genotypingGenetic
Taking a saliva sample for genotyping
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed Parkinson's disease | Patients with incident Parkinson's disease Receives: Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping | |
| Control | Volunteers without diagnosed Parkinson's disease not meeting the exclusion criteria Receives: Diagnostic Test: 16S rRNA gene sequencing; Genetic: DNA-microarray genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome composition of participants
Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample
Measured: Baseline
Genotypes of participants
High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
Measured: Baseline
Hoehn, Yahr scale
The Hoehn and Yahr scale defining five basic stages of PD progression (0-5)
Measured: Baseline
Secondary outcomes (7)
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).
Measured: Baseline
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.
Measured: 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
Measured: Baseline
Change in Stool frequency
Change in the number of stool per week
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Sep 2020
- Primary completion1 Feb 2022
- Study completion25 Feb 2022
Why it stopped: Low recruitment power
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas Biomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119596
- Sponsor's protocol ID
- PSM
- Status last verified
- Feb 2020
- First submitted
- 7 Oct 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04119596
- Acronym / sponsor ID
- PSM
- Conditions
- Parkinson Disease, Genetic Predisposition
- Keywords
- Gut Microbiota, Parkinson's disease, Genetics, Microbiome, FFQ, GPAQ, HADS, MOCA
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low recruitment power
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Atlas BiomedIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed Parkinson's disease | – | Diagnostic Test: 16S rRNA gene sequencing, Genetic: DNA-microarray genotypingPatients with incident Parkinson's disease |
| Control | – | Diagnostic Test: 16S rRNA gene sequencing, Genetic: DNA-microarray genotypingVolunteers without diagnosed Parkinson's disease not meeting the exclusion criteria |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with incident Parkinson's disease from Russia
Key inclusion criteria (2 listed)
- Men and women aged 45 years and over who have been diagnosed with Parkinson's disease
- Subject signed informed consent
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA gene sequencingTaking a stool sample for gut microbiome DNA sequencing | Diagnostic test | Control, Diagnosed Parkinson's disease |
| DNA-microarray genotypingTaking a saliva sample for genotyping | Genetic | Control, Diagnosed Parkinson's disease |
Primary outcome
Gut microbiome composition of participants
Time frame: Baseline
Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample
Genotypes of participants
Time frame: Baseline
High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
Hoehn, Yahr scale
Time frame: Baseline
The Hoehn and Yahr scale defining five basic stages of PD progression (0-5)
7 secondary outcomes
Physical activity questionnaire
Time frame: Baseline
Food frequency questionnaire
Time frame: 12 months before baseline
Change in Stool consistency
Time frame: Baseline
Change in Stool frequency
Time frame: Baseline
Change in Quality of Life: SF-36 questionnaire
Time frame: Baseline
Psychological distress questionnaire
Time frame: Baseline
MOCA scale questionnaire
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Low recruitment power). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Genetic Predisposition, run by Atlas Biomed at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment power). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome composition of participants (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.