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Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.

Sponsor
First People's Hospital of Hangzhou (Other)
Overall Status
Completed
CT.gov ID
NCT06001060
Collaborator
(none)
38
Enrollment
1
Location
7
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    38 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    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
    Actual Study Start Date :
    Oct 1, 2022
    Actual Primary Completion Date :
    Dec 20, 2022
    Actual Study Completion Date :
    May 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    women of reproductive age with elevated homocysteine levels

    Outcome Measures

    Primary Outcome Measures

    1. homocysteine levels [The first day of the trail]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • No recent antibiotic treatment
    Exclusion Criteria:
    • Recently received antibiotics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hangzhou First People's Hospital Hangzhou China

    Sponsors and Collaborators

    • First People's Hospital of Hangzhou

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    First People's Hospital of Hangzhou
    ClinicalTrials.gov Identifier:
    NCT06001060
    Other Study ID Numbers:
    • 2023004
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 21, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Abortion, Spontaneous
    Abortion, Habitual

    Study Results

    No Results Posted as of Aug 21, 2023