Gut Microbiota in Patients With Moyamoya Disease

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

Study Overview

• Status: Recruiting
• Conditions: Moyamoya Disease; Gut Microbiota

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Tiantan Hospital Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MMD group; Consecutive patients diagnosed with MMD during hospitalization in Beijing Tiantan Hospital, Capital Medical University will be recruited.
Healthy control group; Age and sex matched subjects will be invited to join the study as the control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation analysis between gut microbiota in MMD patients and inflammatory cytokines.	IL-4,IL-10,IL-13, IFN-α, TGF-β, IL-1,IL-6, IL-17, IFN-β, IFN-γ and TNF-α	Through study completion，eight months.
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.
The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)	RNF213 p.R4810K	Through study completion，eight months.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Dong Zhang, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Microbiome; Moyamoya Disease; RNF213 p.R4810K
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Moyamoya Disease
• Other Study ID Numbers: KY 2021-072-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No