Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-01-04 @ 6:32 PM
Study NCT ID:
NCT06429358
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2024-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-05-15', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Detailed Report Values', 'timeFrame': "second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.", 'description': 'The test was performed to determine levels of neutrophils'}, {'measure': 'Urine Culture', 'timeFrame': "second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.", 'description': 'Urine Culture:\n\nUrine samples were collected aseptically prior to and after intervention and cultured to detect bacterial pathogens linked with urinary tract infections. This assessment was carried out at two distinct time points:\n\nPre-Intervention: Before beginning the probiotic intervention, baseline urine samples were taken to detect any existing bacterial illnesses and create a point of comparison.\n\nPost-Intervention: After the intervention period, individuals supplied an additional urine sample for culture investigation. This post-intervention evaluation sought to establish any changes in the prevalence of bacterial pathogens, particularly those known to cause urinary tract infection'}, {'measure': 'Leukocytes:', 'timeFrame': "second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.", 'description': 'leukocytes in urine were evaluated'}, {'measure': 'Nitrites:', 'timeFrame': "second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.", 'description': 'presence of nitrites in urine before and after intervention was investigated'}, {'measure': 'pH', 'timeFrame': "second trimester of pregnancy (about 14 week's gestation) and lasted until birth, a period of roughly 26 to 28 weeks.", 'description': 'Urinary pH values were measured'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infections']}, 'descriptionModule': {'briefSummary': 'Urinary tract infections (UTIs) are a significant public health problem affecting more than 150 million people worldwide and causing a significant economic impact of approximately US$ 6 billion annually. It is one of the most common infectious diseases after upper respiratory tract infections. More than 50% of women and at least 12% of men will be affected by urinary tract infections in their lifetime. The probiotic supplement was delivered as easy-to-swallow capsules specifically prepared to maintain the viability and stability of the Lactobacillus rhamnosus GG strain throughout the research period. Participants were told to take the probiotic supplement with water to maximise absorption and efficiency, ideally after meals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': "14 week's gestation with diagnosed UTI", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women aged 18-40 year\n* History of recurrent urinary tract infections (two or more episodes in the past year).\n* Singleton pregnancy.\n\nExclusion Criteria:\n\n* Multiple gestations.\n* History of preterm labor.\n* Chronic medical conditions (e.g., diabetes mellitus, immunodeficiency disorders).\n* Use of antibiotics or probiotics within the past month.'}, 'identificationModule': {'nctId': 'NCT06429358', 'briefTitle': 'The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Frontier Medical and Dental College, Abbotabad'}, 'officialTitle': 'The Role of Probiotics in Preventing Recurrent Urinary Tract Infections in Pregnant Women: A Randomized Control Trial', 'orgStudyIdInfo': {'id': '3388'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic Group', 'description': 'The probiotic group received a daily oral supplement with Lactobacillus rhamnosus. The probiotic supplement was delivered as easy-to-swallow capsules.', 'interventionNames': ['Dietary Supplement: Lactobacillus rhamnosus']}, {'type': 'OTHER', 'label': 'Control Group', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Lactobacillus rhamnosus', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The probiotic supplement was delivered in the form of easy-to-swallow capsules.', 'armGroupLabels': ['Probiotic Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Participants in the control group were given a placebo that looked, tasted, and felt just like the probiotic pill.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abbottābād', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Frontier Medical and Dental College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frontier Medical and Dental College, Abbotabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr Saif ur Rehman', 'investigatorAffiliation': 'Frontier Medical and Dental College, Abbotabad'}}}}