Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-30 @ 6:53 PM
Study NCT ID:
NCT06114303
Status:
TERMINATED
Last Update Posted:
2025-12-02
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This study was terminated early on 16/06/2025 because the initial results obtained from the 14 pairs of patients included were sufficient to satisfactorily address the research question posed in the context of the thesis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-10-27', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptional activity of microbiomes', 'timeFrame': '10 months', 'description': 'Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA'}, {'measure': 'Transcriptomic profiles of the communities', 'timeFrame': '10 months', 'description': 'Transcriptomic profiles of the communities assessed by meta-transcriptomics'}, {'measure': 'Metabolites produced and microbial metabolic pathways', 'timeFrame': '10 months', 'description': 'Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysbiosis']}, 'descriptionModule': {'briefSummary': 'The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and children) re-cultured under anaerobic conditions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The mother/daughter " duos " participating in the study will be drawn from a panel of volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult "Mother" population:\n\n* Women aged 25-40 years;\n* In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or long-term treatment,\n* With a regular bowel movement frequency (at least once every 2 days)\n* BMI between 18.5 and 25\n* Able and willing to participate in the research by complying with the protocol procedures\n* Not objecting to the collection and processing of their personal data\n\nChild "Daughter" population\n\n* Girl between 1 and 2 years old\n* In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or on a long-term basis,\n* With a regular stool frequency (at least once every 2 days)\n* Whose mother does not object to the collection and processing of personal data\n\nExclusion Criteria:\n\nAdult "Mother" population :\n\n* Pregnant or breastfeeding women,\n* Under antibiotic treatment, or having stopped it for less than a month.\n* Under dietary supplementation (prebiotics or probiotics) or having stopped it less than one month before\n* On antidepressants and/or anxiolytics in the month before inclusion\n* Taking a non-steroidal anti-inflammatory drug (NSAID) the month before inclusion.\n* On PPI, or having stopped it less than one month before.\n* Persons under court protection,\n* Person participating in another research study with an ongoing exclusion period,\n\nChild "Daughter" population:\n\n* Outside the WHO normal growth charts (weight for height) for girls aged 0-2 years (below the 3rd percentile or above the 97th percentile)\n* Undergoing antibiotic treatment, or having stopped it less than a month ago.\n* Having taken a non-steroidal anti-inflammatory drug (NSAID) in the month prior to inclusion.\n* On dietary supplements (prebiotics or probiotics) or having stopped them within the last month\n* Subjects participating in another research study with an ongoing exclusion period'}, 'identificationModule': {'nctId': 'NCT06114303', 'acronym': 'EPROMED', 'briefTitle': 'Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota', 'organization': {'class': 'INDUSTRY', 'fullName': 'Larena SAS'}, 'officialTitle': 'Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota', 'orgStudyIdInfo': {'id': 'PIL-RIPH3-EPROMED-023'}}, 'armsInterventionsModule': {'armGroups': [{'label': '"Mother"', 'description': 'Healthy women', 'interventionNames': ['Other: Stool sampling']}, {'label': '"Daughter"', 'description': 'Healthy "daughter" from "Mother" subjects', 'interventionNames': ['Other: Stool sampling']}], 'interventions': [{'name': 'Stool sampling', 'type': 'OTHER', 'description': '1 stool sample is taken during the study with a stool sample kit', 'armGroupLabels': ['"Daughter"', '"Mother"']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Amandine FRY', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larena SAS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Université Paris-Saclay', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}