Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.
1. Study Design 2. Sample Collection 3. Microbial DNA Extraction in Faecal Samples 4. PCR Amplification： 5. Sequencing： 6. HCY Test Principle: 7. Statistical Analysis
1 other identifier
observational
38
1 country
1
Brief Summary
The goal of this observational study is to test the alterations of gut microbiota composition among women of reproductive age with elevated homocysteine levels. The main question it aims to answer is: • the relationship between gut microbiota composition and recurrent abortion. Participants will provide their stool samples to be detected the composition of gut microbiota. . Researchers will compare women of reproductive age with normal homocysteine levels to see if any bacteria were involved in recurrent miscarriages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 14, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedAugust 21, 2023
June 1, 2023
3 months
August 14, 2023
August 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
homocysteine levels
Binding or dimer homocysteine (oxidized form) is reduced to free homocysteine, and then it is catalysed by cysteine β-synthetase (CBS) to react with serine to form cysteine sulfuric acid. Cysteine is then broken down by cysteine β-lyase (CBL) to form homocysteine, pyruvate, and ammonia. Pyruvate is then converted to lactate using lactate dehydrogenase (LDH), where nicotinamide adenine dinucleotide (NADH) is used as a coenzyme. The ratio of NADH to NAD\* is directly proportional to the concentration of homocysteine (△ A340 nm).
The first day of the trail
Study Arms (1)
women of reproductive age with elevated homocysteine levels
Eligibility Criteria
patients or healthy individuals who visited Hangzhou First People's Hospital
You may qualify if:
- No recent antibiotic treatment
You may not qualify if:
- Recently received antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hangzhou First People's Hospital
Hangzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2023
First Posted
August 21, 2023
Study Start
October 1, 2022
Primary Completion
December 20, 2022
Study Completion
May 1, 2023
Last Updated
August 21, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share