Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT06001060
Status:
COMPLETED
Last Update Posted:
2023-08-21
First Post:
2023-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000026', 'term': 'Abortion, Habitual'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2023-08-14', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'homocysteine levels', 'timeFrame': 'The first day of the trail', 'description': '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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Miscarriage']}, 'descriptionModule': {'briefSummary': '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:\n\n• the relationship between gut microbiota composition and recurrent abortion. Participants will provide their stool samples to be detected the composition of gut microbiota. .\n\nResearchers will compare women of reproductive age with normal homocysteine levels to see if any bacteria were involved in recurrent miscarriages.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "patients or healthy individuals who visited Hangzhou First People's Hospital", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No recent antibiotic treatment\n\nExclusion Criteria:\n\n* Recently received antibiotics'}, 'identificationModule': {'nctId': 'NCT06001060', 'briefTitle': 'Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2023004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'women of reproductive age with elevated homocysteine levels'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}