Study of the Genome, Gut Metagenome and Diet of Patients With Incident Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Genotypes of participants
研究概览
简要总结
A case-control study to identify microbiome and genetic differences between healthy subjects and patients with incident Parkinson's disease.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 45 years and over who have been diagnosed with Parkinson's disease
- •Subject signed informed consent
排除标准
- •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
结局指标
主要结局
Genotypes of participants
时间窗: Baseline
High-throughput SNP profiling obtained via DNA-microarray genotyping of the DNA extracted from the saliva sample
Gut microbiome composition of participants
时间窗: Baseline
Bacterial relative abundance obtained via sequencing the DNA extracted from the stool sample
Hoehn, Yahr scale
时间窗: Baseline
The Hoehn and Yahr scale defining five basic stages of PD progression (0-5)
次要结局
- Food frequency questionnaire(12 months before baseline)
- Physical activity questionnaire(Baseline)
- Change in Stool consistency(Baseline)
- Change in Stool frequency(Baseline)
- MOCA scale questionnaire(Baseline)
- Psychological distress questionnaire(Baseline)
- Change in Quality of Life: SF-36 questionnaire(Baseline)