Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01180556
Status:
COMPLETED
Last Update Posted:
2016-03-29
First Post:
2010-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Probiotics in Childhood Abdominal Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-27', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and intensity of abdominal pain', 'timeFrame': 'Eight weeks', 'description': 'Number of pain episodes and pain intensity based on a visual scale'}], 'secondaryOutcomes': [{'measure': 'School absenteeism', 'timeFrame': 'Eight weeks', 'description': 'Number of patients with school absenteeism'}, {'measure': 'Other gastrointestinal symptoms', 'timeFrame': 'Eight weeks', 'description': 'Any gastrointestinal symptom such as nausea, vomiting, diarrhea, bloating'}, {'measure': 'Adverse effects related to treatment', 'timeFrame': 'Eight weeks', 'description': 'Any adverse effects related to the probiotic supplementation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['childhood', 'abdominal pain', 'probiotics'], 'conditions': ['Abdominal Pain']}, 'referencesModule': {'references': [{'pmid': '27156182', 'type': 'DERIVED', 'citation': 'Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.', 'detailedDescription': 'Prospective randomized double-blind placebo-controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children\n\nExclusion Criteria:\n\n* Any chronic or organic illness'}, 'identificationModule': {'nctId': 'NCT01180556', 'briefTitle': 'Effect of Probiotics in Childhood Abdominal Pain', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'The Effect of Probiotics in Childhood Abdominal Pain', 'orgStudyIdInfo': {'id': 'Sor493009ctil'}, 'secondaryIdInfos': [{'id': '4930', 'type': 'OTHER', 'domain': 'SMC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotics supplementation', 'description': 'Supplementation by probiotics for 4 weeks', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Supplementation of placebo for 4 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['probiotic agent, L. reuteri'], 'description': 'Daily oral supplementation for four weeks', 'armGroupLabels': ['Probiotics supplementation']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['placebo tablets'], 'description': 'Placebo administration', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Zvi Weizman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}