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

Recurrent Miscarriage Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06001060
• Other study ID #: 2023004
• Status: Completed
• Start date: October 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 1, 2023
• Est. primary completion date: December 20, 2022
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• No recent antibiotic treatment

Exclusion Criteria:

• Recently received antibiotics

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Recurrent Miscarriage

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	homocysteine levels	Binding or dimer homocysteine (oxidized form) is reduced to free homocysteine, and then it is catalysed by cysteine ß-synthetase (CBS) to react with serine to form cysteine sulfuric acid. Cysteine is then broken down by cysteine ß-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