Moyamoya DiseaseNCT04890782
Gut Microbiota in Patients With Moyamoya Disease
An observational study of Moyamoya Disease and Gut Microbiota, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study is to find out the association between gut microbiota and moyamoya disease. Read more about this study
- Who is it for?
- Ages 2 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease, Gut Microbiota
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, 100000
Dong Zhang, MD, 13801121292, zhangdong0660@aliyun.com
Peicong Ge, MD, 15010545727, gepeicong@163.com
About this study
This study is to find out the association between gut microbiota and moyamoya disease.
Read the 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.
- Conditions
- Moyamoya Disease, Gut Microbiota
- Keywords
- Moyamoya Disease, Microbiome, RNF213 p.R4810K, MRI
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion，eight months.
Secondary outcomes (3)
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
Measured: 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;
Measured: Through study completion，eight months.
The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)
RNF213 p.R4810K
Measured: Through study completion，eight months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 May 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Zhang, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890782
- Sponsor's protocol ID
- KY 2021-072-01
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota in Patients With Moyamoya Disease
- ClinicalTrials.gov ID
- NCT04890782
- Acronym / sponsor ID
- KY 2021-072-01
- Conditions
- Moyamoya Disease, Gut Microbiota
- Keywords
- Moyamoya Disease, Microbiome, RNF213 p.R4810K, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diversity analysis of genes and species between MMD patients and the control group
Time frame: 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.
Analysis of differences in intestinal microbiota between MMD patients and the control group
Time frame: 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
Time frame: 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.
Analysis of metabolites of the intestinal microbiota of MMD patients in comparison to the control group
Time frame: Through study completion，eight months.
Metabolites of the intestinal microbiota between two groups
3 secondary outcomes
Correlation analysis between gut microbiota in MMD patients and inflammatory cytokines.
Time frame: Through study completion，eight months.
Correlation analysis between gut microbiota in MMD patients and neuroimaging markers and cognitive status.
Time frame: Through study completion，eight months.
The differences of composition of gut microbiota among the genotypes (RNF213 p.R4810K)
Time frame: Through study completion，eight months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Zhang, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease and Gut Microbiota, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Zhang, MD (13801121292, zhangdong0660@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diversity analysis of genes and species between MMD patients and the control group (time frame: Through study completion，eight months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.