Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:22 AM
Study NCT ID:
NCT07425704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics, Antibiotics and the Post-Antibiotic Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-13', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics', 'timeFrame': 'From date of randomization until the end of the study (90 days)'}], 'secondaryOutcomes': [{'measure': 'Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention.', 'timeFrame': 'One month post antibiotic treatment/ intervention (30 days)', 'description': 'A daily gastrointestinal/Vaginal health symptom record sheet which involves ticking off symptoms is present.'}, {'measure': 'Bowel habit diary to measure gastrointestinal health post Intervention', 'timeFrame': 'One month post antibiotic treatment/ intervention (30 days)', 'description': 'A bowel habit diary questionnaire to be completed for every attempted bowel motion during the study. Questions include; 1. Were you able to pass a stool?, 2. Did you feel an urgent need to pass the bowel motion?, 3. Did you strain to start the bowel motion?, 4. Were you left with a feeling of incomplete evacuation?, 5. Please rate the appearance of your bowel motion using the bristol stool score (1-7).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Probiotic', 'Microbiome']}, 'descriptionModule': {'briefSummary': 'Antibiotic therapy can cause gastrointestinal dysbiosis and this study will assess the impact of probiotic supplementation on microbiological composition and functionality pre- and post- antibiotic therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults, aged 18-40.\n2. Been prescribed an oral dose of cephalosporin antibiotic lasting 5 - 10 days.\n3. Willing to provide stool samples and, for women, vaginal samples.\n4. Willing to avoid consumption of any other probiotic capsules/tablets during the study.\n\nExclusion Criteria:\n\n1. If antibiotics prescribed are intended to treat any gastrointestinal or vaginally related issue.\n2. Any antibiotic intake within the last 3 months.\n3. Immunodeficient or undergoing immunosuppressive therapy.\n4. Currently diagnosed with diabetes/cardiovascular disease/cancer/dementia.\n5. Any unexplained loss of weight in recent months.\n6. Known to be pregnant or \\<3 months postpartum.'}, 'identificationModule': {'nctId': 'NCT07425704', 'briefTitle': 'Probiotics, Antibiotics and the Post-Antibiotic Microbiota', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cultech Ltd'}, 'officialTitle': 'Probiotics, Antibiotics and the Post-Antibiotic Microbiota', 'orgStudyIdInfo': {'id': 'PAPAM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day', 'interventionNames': ['Dietary Supplement: Lab4S']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lab4S', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sofia', 'country': 'Bulgaria', 'contacts': [{'name': 'Maya Dabcheva', 'role': 'CONTACT', 'email': 'maya.dabcheva@comac-medical.com', 'phone': '+359887113036'}], 'facility': 'Comac Medical', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'centralContacts': [{'name': 'Maya Dabcheva', 'role': 'CONTACT', 'email': 'maya.dabcheva@comac-medical.com', 'phone': '+359887113036'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cultech Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}