Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT05319067
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2022-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2022-04-01', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'α-diversity of the gut microbiota between groups', 'timeFrame': 'Day 0', 'description': "N index of a stool sample measured by the Shannon index (H\\^') which incorporates the total number of different Operational Taxonomic Units and the relative proportions of these Operational Taxonomic Units."}], 'secondaryOutcomes': [{'measure': 'The β-diversity of the gut microbiota between groups', 'timeFrame': 'Day 0', 'description': 'Operational Taxonomic Units measured by Bray Curtis Index'}, {'measure': 'The number of bacterial genera present in the gut microbiota between groups', 'timeFrame': 'Day 0', 'description': 'Relative abundance Operational Taxonomic Units present'}, {'measure': 'The prevalence of multi-resistant bacteria', 'timeFrame': 'Day 0', 'description': '% of isolated bacteria producing extended spectrum betalactamase, carbapenemase-producing Enterococcus faecium and glycopeptide-resistant Enterococcus faecium and bacteria resistant to trimethoprim-sulfamethoxazole'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibiotic prophylaxis', 'Microbiota'], 'conditions': ['Vesicoureteral Reflux 3']}, 'descriptionModule': {'briefSummary': 'Urinary tract infections are very common in pediatrics. Urinary antibiotic prophylaxis is commonly used in children with malformative uropathies. Long-term, low-dose antibiotic prophylaxis with trimethoprim-sulfamethoxazole has been associated with a decrease in the number of urinary tract infections in susceptible children, but not systematically with a decrease in the risk of renal scarring (depending of uropathy stage).\n\nLong-term antibiotic prophylaxis has implications for the acquisition of antibiotic resistance. A child receiving antibiotic prophylaxis for urinary tract infection is around 6 times more likely to develop a multidrug-resistant infection. In the general population, the microbiota of children treated with curative antibiotics is less diverse in terms of species and strains. In addition, short-term compositional changes are observed between consecutive samples of children treated with antibiotics.\n\nThe gut microbiota modulates the immune system, in particular via metabolites (SCFA, polysaccharide A) produced by bacteria that modify the expansion and function of regulatory T-cells. The disturbances of the intestinal microbiota play a role in the medium and long term on the acquisition of pathologies, such as atopy.\n\nThe study authors wish to describe the intestinal microbiota of children with vesico-ureteral reflux treated long-term with trimethoprim-sulfamethoxazole and compared it those not receiving antibiotic prophylaxis and to healthy children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For the purpose of the study three groups of children will be constituted:\n\nChildren aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis; Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis; Controls: Healthy children aged 1 to 3 years.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must be a member or beneficiary of a health insurance plan\n* Patient with no objection to participation in the study from the parent or guardian\n* Child with a diversified diet.\n\n o Specific inclusion criteria for group 1 (cases):\n* Child with grade 3 or higher vesicoureteral reflux.\n* Child on trimethoprim-sulfamethoxazole therapy for at least 5 months.\n\n o Specific inclusion criteria for group 2 (controls):\n* Child with uropathy and without long-term trimethoprim-sulfamethoxazole treatment.\n\n o Specific inclusion criteria for group 3 (healthy controls):\n* Child without uropathy or long-term trimethoprim-sulfamethoxazole treatment.\n\nExclusion Criteria:\n\n* Chronic digestive pathology\n* Acute gastroenteritis or infectious colitis within last 15 days.\n* Curative antibiotic therapy taken less than one month ago.\n* Chronic inflammatory bowel disease or other localizations\n* Congenital or acquired immune deficiency (current treatment with methotrexate, biotherapies, immunosuppressants)\n* Patient participating in a category 1 trial likely to modify the intestinal microbiota.\n* Patient in an exclusion period determined by another study.\n* Patient under court protection, guardianship or curatorship.\n* Patient for whom it is impossible to give informed information to person with parental authority.'}, 'identificationModule': {'nctId': 'NCT05319067', 'acronym': 'PROPHYBIOTA', 'briefTitle': 'Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Study of Gut Microbiota Diversity in Children Aged 1-3 Years on Prolonged Antibiotic Prophylaxis for Grade 3 or Higher Vesicoureteral Reflux Compared With 2 Age-matched Control Groups', 'orgStudyIdInfo': {'id': 'NIMAO/2021-2/AF-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Children aged 1 to 3 years with vesico ureteral reflux of grade 3 or higher, under antibiotic prophylaxis', 'interventionNames': ['Other: Stool sampling']}, {'label': 'Controls', 'description': 'Children aged 1 to 3 years with uropathy, without antibiotic prophylaxis', 'interventionNames': ['Other: Stool sampling']}, {'label': 'Healthy Controls', 'description': 'Healthy children aged 1 to 3 years.', 'interventionNames': ['Other: Stool sampling']}], 'interventions': [{'name': 'Stool sampling', 'type': 'OTHER', 'description': 'Stool sample taken at home 24 hours before hospital visit', 'armGroupLabels': ['Cases', 'Controls', 'Healthy Controls']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Denis Morin', 'role': 'CONTACT', 'email': 'd-morin@chu-montpellier.fr', 'phone': '04.67.33.64.28'}, {'name': 'Denis Morin', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicolas Kalfa', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anissa Megzari', 'role': 'CONTACT', 'email': 'drc@chu-nimes.fr', 'phone': '04.66.68.42.36'}, {'name': 'Anne Filleron', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Guillaume Germier', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tu Anh Tran', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Massimo Di Maio', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Catherine Dunyach-Remy', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean-Philippe Lavigne', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Edith Sabatier', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Margot Ollivier', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sarah Garnier', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Viviane Wittmeyer', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'centralContacts': [{'name': 'Anne Filleron', 'role': 'CONTACT', 'email': 'anne.filleron@chu-nimes.fr', 'phone': '04.66.68.32.86'}], 'overallOfficials': [{'name': 'Anne Filleron', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Nimes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}