Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 4:06 AM
Study NCT ID:
NCT06169566
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-11-27', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gut microbiome in polycystic ovary syndrome', 'timeFrame': '12 months', 'description': 'Gut microbiome will be evaluated by metagenomic analysis of the stool exam of PCOS patient before and after receive synbiotics'}], 'secondaryOutcomes': [{'measure': 'synbiotics effect on reproductive and cardiovascular risk', 'timeFrame': '12 months', 'description': 'evaluation of the reproductive clinical (menstrual regularity, polycystic ovarian morphology on the ultrasound) and serum marker of cardiovascular risk (Lipid profile, HbA1C, fasting blood glucose, hsCRP) will be evaluated compare between synbiotics and placebo groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PCOS- Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effect of synbiotics and placebo in Thai women with polycystic ovary syndrome. The main questions it aims to answer are:\n\n* Do synbiotics have a positive effect on the gut microbiome?\n* Do synbiotics have a positive effect on reproductive outcomes?\n* Do synbiotics have a positive effect on cardiovascular outcomes? Participants will be randomized, and blinded to receive either synbiotics or placebo.\n\nWhile placebo is a comparison group: Researchers will compare with placebo to see if the effects on reproductive and cardiovascular risk differ.', 'detailedDescription': 'Analysis of gut microbiome in Thai women with polycystic ovary syndrome and the synbiotics effect on reproductive and cardiovascular risk: A randomized controlled trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- PCOS\n\nExclusion Criteria:\n\n* ATB use'}, 'identificationModule': {'nctId': 'NCT06169566', 'acronym': 'PCOS', 'briefTitle': 'The Synbiotics Effects in Polycystic Ovary Syndrome: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maharaj Nakorn Chiang Mai Hospital'}, 'officialTitle': 'Analysis of Gut Microbiome in Thai Women With Polycystic Ovary Syndrome and the Synbiotics Effect on Reproductive and Cardiovascular Risk: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OBG-2566-0568'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'synbiotics', 'interventionNames': ['Dietary Supplement: synbiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-intervention', 'description': 'placebo', 'interventionNames': ['Combination Product: placebo']}], 'interventions': [{'name': 'synbiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': 'synbiotics', 'armGroupLabels': ['Intervention']}, {'name': 'placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'placebo', 'armGroupLabels': ['non-intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'contacts': [{'name': 'Ploywarong Rueangket', 'role': 'CONTACT', 'email': 'ploywarong.24@gmail.com', 'phone': '800-555-5555'}, {'name': 'Ploywarong Rueangket', 'role': 'CONTACT', 'email': 'ploywarong.24@gmail.com'}, {'name': 'Ploywarong Rueangket', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maharaj Nakorn Chiang Mai Hospital', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Ploywarong Rueangket, MD.', 'role': 'CONTACT', 'email': 'ploywarong.24@gmail.com', 'phone': '66804492863'}, {'name': 'Pisanu Rueangket', 'role': 'CONTACT', 'email': 'ploywarong.24@gmail.com', 'phone': '66804492863'}], 'overallOfficials': [{'name': 'Ploywarong Rueangket, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of obstetrics and gynecoloy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maharaj Nakorn Chiang Mai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Ploywarong Rueangket', 'investigatorAffiliation': 'Maharaj Nakorn Chiang Mai Hospital'}}}}