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

August 14, 2023 updated by: First People's Hospital of Hangzhou

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • Hangzhou First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients or healthy individuals who visited Hangzhou First People's Hospital

Description

Inclusion Criteria:

  • No recent antibiotic treatment

Exclusion Criteria:

  • Recently received antibiotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
women of reproductive age with elevated homocysteine levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
homocysteine levels
Time Frame: 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).
The first day of the trail

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

August 14, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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