Gut Microbiota in Patients With Moyamoya Disease

Gut Microbiota Clinical Trial

Official title:

Gut Microbiota in Patients With Moyamoya Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890782
• Other study ID #: KY 2021-072-01
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Beijing Tiantan Hospital
• Contact: Dong Zhang, MD
• Phone: 13801121292
• Email: zhangdong0660[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiota
• Moyamoya Disease

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diversity analysis of genes and species between MMD patients and the control group	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.	Through study completion,eight months.
Primary	Analysis of differences in intestinal microbiota between MMD patients and the control group	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.	Through study completion,eight months.
Primary	Analysis of functional differences in the intestinal microbiota of MMD patients in comparison to the control group	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.	Through study completion,eight months.
Primary	Analysis of metabolites of the intestinal microbiota of MMD patients in comparison to the control group	Metabolites of the intestinal microbiota between two groups	Through study completion,eight months.
Secondary	Correlation analysis between gut microbiota in MMD patients and inflammatory cytokines.	IL-4,IL-10,IL-13, IFN-a, TGF-ß, IL-1,IL-6, IL-17, IFN-ß, IFN-? and TNF-a	Through study completion,eight months.
Secondary	Correlation analysis between gut microbiota in MMD patients and neuroimaging markers and cognitive status.	MRI: BOLD, DWI, QSM, CUBE, ASL, T1, T2; Cognitive status: Wisdom, Attention, Memory, Linguistic fluency;	Through study completion,eight months.
Secondary	The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)	RNF213 p.R4810K	Through study completion,eight months.