Clinical trial NCT04890782: Gut Microbiota in Patients With Moyamoya Disease
Official title: Gut Microbiota in Patients With Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Moyamoya Disease
Gut Microbiota
Keywords: Moyamoya Disease
Microbiome
RNF213 p.R4810K
MRI
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients diagnosed with MMD during hospitalization in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria. Control group will be recruited from medical out patient clinic.

Brief summary: This study is to find out the association between gut microbiota and moyamoya disease.

Detailed description: Moyamoya disease (MMD) is a rare cerebrovascular disorder, it is a major cause of stroke in children and young adults in Japan, Korea, and China, but its pathogenesis is not yet clear. Dysbiosis of gut microbiota may play a role in the pathological change of MMD. In this research, the investigators would perform metagenomic sequencing to find the characteristics of gut microbiota of MMD and to explore the correlations with metabolic, immune, and clinical symptoms. This research will not only help the understanding of the pathophysiology of MMD, but also may provide a reference for the selection of clinical treatment options.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of MMD by DSA according to the Japanese guidelines published in 2012,
2. Stenosis or occlusion of the terminal internal carotid and the proximal middle and anterior cerebral arteries and unilateral or bilateral involvement
3. Age: 2-60 years old.

Exclusion Criteria:

1. Moyamoya syndrome,
2. Pregnancy,
3. Evidence of gastrointestinal infection/ inflammation/ obstruction
4. History of partial or total resection of small or large bowel, as well as gut reanastomosis,
5. Use of antibiotics within 2 weeks prior to symptoms onset,
6. Gastrointestinal malignancy
7. Any hospitalization within 3 months before recruitment

Primary outcomes:
measure: Diversity analysis of genes and species between MMD patients and the control group
timeFrame: Through study completion，eight months.
measure: Analysis of differences in intestinal microbiota between MMD patients and the control group
timeFrame: Through study completion，eight months.
measure: Analysis of functional differences in the intestinal microbiota of MMD patients in comparison to the control group
timeFrame: Through study completion，eight months.
measure: Analysis of metabolites of the intestinal microbiota of MMD patients in comparison to the control group
timeFrame: Through study completion，eight months.
Secondary outcomes:
measure: Correlation analysis between gut microbiota in MMD patients and inflammatory cytokines.
timeFrame: Through study completion，eight months.
measure: Correlation analysis between gut microbiota in MMD patients and neuroimaging markers and cognitive status.
timeFrame: Through study completion，eight months.
measure: The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)
timeFrame: Through study completion，eight months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Dong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: