Gut Microbiota in Patients With Moyamoya Disease

NCT04890782 | Unknown

• 1 other identifier: KY 2021-072-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moyamoya Disease; Gut Microbiota

Keywords

Moyamoya Disease; Microbiome; RNF213 p.R4810K; MRI

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Correlation analysis between gut microbiota in MMD patients and inflammatory cytokines.

  Through study completion，eight months.

• Correlation analysis between gut microbiota in MMD patients and neuroimaging markers and cognitive status.

  Through study completion，eight months.

• The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)

  Through study completion，eight months.

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital Capital Medical University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Moyamoya Disease

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong Zhang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhang, MD

CONTACT

13801121292; zhangdong0660@aliyun.com

Peicong Ge, MD

CONTACT

15010545727; gepeicong@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)