Gut Microbiota in Patients With Moyamoya Disease

• Conditions: Moyamoya Disease; Gut Microbiota

• Registration Number: NCT04890782
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-01
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analysis of metabolites of the intestinal microbiota of MMD patients in comparison to the control group	Through study completion，eight months.	Metabolites of the intestinal microbiota between two groups
Analysis of differences in intestinal microbiota between MMD patients and the control group	Through study completion，eight months.	The Spearman correlation coefficient between genes will be calculated, and genes with strong correlation will be grouped into one cluster, as a CAG. The abundance of CAGs in each sample will be determined Furthermore, the significantly enriched species in the control and MMD groups will be enumerated for network display.
Analysis of functional differences in the intestinal microbiota of MMD patients in comparison to the control group	Through study completion，eight months.	The LEfSe discriminant analysis will be used to screen for significant differences between groups. The dimensionality reduction will be implemented by LDA, and the impact of function difference will be evaluated to obtain the LDA score and identify significantly different functions between groups.
Diversity analysis of genes and species between MMD patients and the control group	Through study completion，eight months.	Based on the gene and species composition of each sample, the Chao1 and Shannon indexes, as well as the observed OTUs (operational taxonomic units), will be calculated in order to identify the differences in gene and species diversity for each group.

Secondary Outcome Measures

Name	Time	Method
The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)	Through study completion，eight months.	RNF213 p.R4810K
Correlation analysis between gut microbiota in MMD patients and neuroimaging markers and cognitive status.	Through study completion，eight months.	MRI: BOLD, DWI, QSM, CUBE, ASL, T1, T2; Cognitive status: Wisdom, Attention, Memory, Linguistic fluency;
Correlation analysis between gut microbiota in MMD patients and inflammatory cytokines.	Through study completion，eight months.	IL-4,IL-10,IL-13, IFN-α, TGF-β, IL-1,IL-6, IL-17, IFN-β, IFN-γ and TNF-α

Trial Locations

Locations (1)

Beijing Tiantan Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China