Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01501305
Status:
UNKNOWN
Last Update Posted:
2011-12-29
First Post:
2011-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Carob and Probiotics on Acute Diarrhea in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-28', 'studyFirstSubmitDate': '2011-12-26', 'studyFirstSubmitQcDate': '2011-12-28', 'lastUpdatePostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in diarrhea', 'timeFrame': 'One week', 'description': 'Measurement of number of vomiting and diarrhea bowel movements before and after intervention'}], 'secondaryOutcomes': [{'measure': 'Number of days until no diarrhea bowel movements', 'timeFrame': '1 week', 'description': 'Measurement of number of days until diarrhea is gone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['influence', 'carob powder', 'probiotics', 'duration'], 'conditions': ['Diarrhea']}, 'descriptionModule': {'briefSummary': 'Comparison of Carob powder with probiotics vs oral hydration solution in diarrhea treatment in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute diarrhea\n\nExclusion Criteria:\n\n* Dehydration\n* Chronic diseases\n* Chronic diarrhea (more than 2 weeks)\n* Septic shock\n* Hypovolemia\n* On medication\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01501305', 'briefTitle': 'Influence of Carob and Probiotics on Acute Diarrhea in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': '68-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Mineral rehydration solution', 'interventionNames': ['Dietary Supplement: Mineral solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Carob powder', 'description': 'Carob powder and probiotics', 'interventionNames': ['Dietary Supplement: Carob powder with probiotics']}], 'interventions': [{'name': 'Mineral solution', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Rehydration mineral solution', 'armGroupLabels': ['Placebo']}, {'name': 'Carob powder with probiotics', 'type': 'DIETARY_SUPPLEMENT', 'description': '7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone', 'armGroupLabels': ['Carob powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Jamal Garah, MD', 'role': 'CONTACT', 'phone': '972-4-6304333'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}