Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01046656
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2009-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
L Reuteri for the Prevention of Nosocomial Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-27', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nosocomial diarrhea (passage of 3 or more loose or watery stools in a 24-hour period that will occur more than 72 hours after admission)', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay in days', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}, {'measure': 'Recurrent diarrhea - recurrence of diarrhea after 48h of normal stools', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}, {'measure': 'Chronic diarrhea - diarrhea beyond 14 days', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}, {'measure': 'Diarrhea - the passage of 3 or more loose of watery stools in a 24 h period', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}, {'measure': 'Rotavirus infection - detection of rotavirus or antigen in the stools', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}, {'measure': 'Duration of diarrhea - time till the last loose watery stools from the onset of diarrhea measured in days)', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}, {'measure': 'Need for rehydration', 'timeFrame': 'from 72nd hrs till the and of hospitalization no longer than 14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nosocomial infection', 'diarrhea', 'Lactobacillus reuteri', 'gastroenteritis', 'rotavirus'], 'conditions': ['Nosocomial Infection', 'Diarrhea', 'Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '22306046', 'type': 'DERIVED', 'citation': 'Wanke M, Szajewska H. Lack of an effect of Lactobacillus reuteri DSM 17938 in preventing nosocomial diarrhea in children: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2012 Jul;161(1):40-3.e1. doi: 10.1016/j.jpeds.2011.12.049. Epub 2012 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In children, it is commonly caused by enteric pathogens, especially rotavirus. The reported incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may prolong the hospital stay and increase medical costs. One of the potential strategies for the prevention of nosocomial infections is the use of probiotics. The number of studies have shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea. However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial gastroenteritis in a pediatric hospital setting.', 'detailedDescription': 'Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in 5 drops of oil suspension or a comparable placebo once daily for the entire duration of their hospital stay.\n\nPatients will be evaluated daily for stool number and consistency. In case of loose or watery stools occurring within 3 days after discharge, patients will be advised to contact hospital physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed for bacteria with standard stool cultures and rotavirus and adenovirus antigen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 1-48 mo\n* cause of hospitalization must be other than acute gastroenteritis or diarrhea\n\nExclusion Criteria:\n\n* acute gastroenteritis within 3 days before admission\n* other symptoms which suggest gastroenteritis\n* usage of probiotics and/or prebiotics within 7 days before admission\n* visible blood in the stool\n* patient in bad condition\n* lack of approval from patients parents\n* breastfeeding\n* no compliance'}, 'identificationModule': {'nctId': 'NCT01046656', 'acronym': 'PND', 'briefTitle': 'L Reuteri for the Prevention of Nosocomial Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Efficacy of Lactobacillus Reuteri DSM 17938 in the Prevention of Nosocomial Diarrhea in Children. Randomized Double-blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '152/2009'}, 'secondaryIdInfos': [{'id': '152/2009'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lactobacillus reuteri (DSM 17938)', 'type': 'DIETARY_SUPPLEMENT', 'description': '5 drops once daily (10(8) CFU) for the entire duration of hospital stay'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-184', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'The Medical University of Warsaw, Department of Paediatrics', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hania Szajewska', 'oldOrganization': 'Department of Paediatrics, The Medical University of Warsaw'}}}}