Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-04 @ 12:33 PM
Study NCT ID:
NCT03334604
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 350}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of antibiotic-associated diarrhea', 'timeFrame': 'Up to 7th day after antibiotic cessation.', 'description': 'Antibiotic-associated diarrhea will be defined as 3 or more loose or watery stools (a score of A on the Amsterdam Infant Stool Scale or 5-7 on the Bristol Stool Form scale) per day in a 24-hour period, caused by C. difficile infection or of otherwise unexplained aetiology after testing for common diarrhoeal pathogens (rotavirus, adenovirus, norovirus, Campylobacter spp., Salmonella spp., Shigella spp., and Yersinia spp.), occurring during the intervention period.'}], 'secondaryOutcomes': [{'measure': 'Incidence of antibiotic-associated diarrhea - alternative definition 1', 'timeFrame': 'Up to 7th day after antibiotic cessation.', 'description': '≥3 loose or watery stools per day for a minimum of a 48-hour period caused by C. difficile infection or of otherwise unexplained aetiology.'}, {'measure': 'Incidence of antibiotic-associated diarrhea - alternative definition 2', 'timeFrame': 'Up to 7th day after antibiotic cessation.', 'description': '≥2 loose or watery stools per day for a minimum of a 24-hour period caused by C. difficile infection or of otherwise unexplained aetiology.'}, {'measure': 'Incidence of diarrhea', 'timeFrame': 'Up to 7th day after antibiotic cessation.', 'description': '≥3 loose or watery stools per day for a minimum of 24 hours regardless of its aetiology.'}, {'measure': 'Clostridium difficile-associated diarrhea', 'timeFrame': 'Up to 7th day after antibiotic cessation.', 'description': '≥3 loose or watery stools per day for a minimum of 24 hours caused by C. difficile confirmed by the presence of toxin-producing C. difficile in stools.'}, {'measure': 'Duration of diarrhea', 'timeFrame': 'Up to 7th day after antibiotic cessation.', 'description': 'Defined as the time until the normalisation of stool consistency according to the Bristol Stoo Form (BSF) or Amsterdam Infant Stool Scale (AISS) - on BSF numbers 1, 2, 3 and 4; on AISS scale, letters B or C, and the presence of normal stools for 48 h.'}, {'measure': 'Discontinuation of the antibiotic treatment due to severity of diarrhoea', 'timeFrame': 'Up to 7th day after antibiotic cessation.'}, {'measure': 'Hospitalisation caused by diarrhoea', 'timeFrame': 'Up to 7th day after antibiotic cessation.'}, {'measure': 'Need for intravenous rehydration', 'timeFrame': 'Up to 7th day after antibiotic cessation.'}, {'measure': 'Adverse events', 'timeFrame': 'Up to 7th day after antibiotic cessation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antibiotic-associated diarrhea', 'probiotics'], 'conditions': ['Antibiotic-associated Diarrhea']}, 'referencesModule': {'references': [{'pmid': '38967929', 'type': 'DERIVED', 'citation': 'Dierikx TH, Malinowska AM, Lukasik J, Besseling-van der Vaart I, Belzer C, Szajewska H, de Meij TGJ; Multispecies Probiotic in AAD Study Group. Probiotics and Antibiotic-Induced Microbial Aberrations in Children: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2418129. doi: 10.1001/jamanetworkopen.2024.18129.'}, {'pmid': '35727573', 'type': 'DERIVED', 'citation': 'Lukasik J, Dierikx T, Besseling-van der Vaart I, de Meij T, Szajewska H; Multispecies Probiotic in AAD Study Group. Multispecies Probiotic for the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial. JAMA Pediatr. 2022 Sep 1;176(9):860-866. doi: 10.1001/jamapediatrics.2022.1973.'}, {'pmid': '29866789', 'type': 'DERIVED', 'citation': 'Lukasik J, Szajewska H. Effect of a multispecies probiotic on reducing the incidence of antibiotic-associated diarrhoea in children: a protocol for a randomised controlled trial. BMJ Open. 2018 Jun 4;8(5):e021214. doi: 10.1136/bmjopen-2017-021214.'}]}, 'descriptionModule': {'briefSummary': 'In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) in reducing the risk of antibiotic-associated diarrhoea in a group of children undergoing antibiotic therapy for common infections.', 'detailedDescription': 'Certain individual probiotic strains have been proven to be effective in reducing the risk of antibiotic-associated diarrhoea (AAD). However, the effects of using multispecies probiotics remain unclear. The investigators aim to assess the effectiveness of a specific multispecies probiotic preparation (Ecologic AAD Kids) in reducing the incidence of AAD in children.\n\nIn this trial, a total of 350 children aged 3 months to 18 years, undergoing antibiotic treatment, will be randomly allocated to receive either a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) at a total dose of 10\\^10 colony-forming units daily, or a placebo, from the first day of antibiotic treatment until 7 days after antibiotic cessation. The primary outcome measure will be the incidence of AAD, defined as ≥3 loose or watery stools (a score of A on the Amsterdam Infant Stool Scale for children younger than 1 year and a score of 5-7 on the Bristol Stool Form scale for children older than 1 year) in 24 hours, caused either by Clostridium difficile or of otherwise unexplained aetiology (after testing for common diarrhoeal pathogens), occurring during and/or up to 7 days after the end of the antibiotic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children receiving oral or intravenous antibiotics for common infections, willing and able to start the probiotic intervention within 24 hours after the start of antibiotic intake, receiving broad-spectrum antibiotics (broad-spectrum penicillins, cephalosporins, fluoroquinolones, clindamycin).\n\nExclusion Criteria:\n\n* prior use of antibiotics within the previous 4 weeks, presence of a severe or generalised infection, history of severe chronic disease (e.g., cancer, inflammatory bowel disease, tuberculosis), critical/life-threatening illness, immunodeficiency, history of pre-existing diarrhoea within the previous 4 weeks, exclusive breastfeeding, allergy or hypersensitivity to any component of the study product, tube-feeding, use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic product containing L rhamnosus GG or S boulardii 14 days before and during the study.'}, 'identificationModule': {'nctId': 'NCT03334604', 'briefTitle': 'The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.', 'orgStudyIdInfo': {'id': 'AAD2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multispecies probiotic group', 'description': '175 participants.', 'interventionNames': ['Dietary Supplement: Multispecies probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '175 participants.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Multispecies probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Multispecies probiotic consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 at a dose of 5x10\\^9 Colony Forming Units (CFU), twice daily, orally.', 'armGroupLabels': ['Multispecies probiotic group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo identical in taste, smell and color to the multispecies probiotic.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1061', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG location West', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1092', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'OLVG location East', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location AMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '55-100', 'city': 'Trzebnica', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Department of Paediatrics, St. Hedwig of Silesia Hospital'}, {'zip': '02-091', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Paediatrics, The Medical University of Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Jan Łukasik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Paediatrics, The Medical University of Warsaw, Poland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The data collected in the course of this study are available from the Principal Investigator upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Winclove Probiotics B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}