Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-01-01 @ 1:56 PM
Study NCT ID:
NCT01269892
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2011-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-03', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of diarrhea', 'timeFrame': 'at seven days after admission', 'description': 'Duration of diarrhea corresponded to the time from enrollment to the cessation of diarrhea, which was defined as the passage of the last watery or loose stool before passage of two consecutive formed stools or no stool in a 24-hour period.'}], 'secondaryOutcomes': [{'measure': 'changes in weight gaining', 'timeFrame': 'at seven days after admission', 'description': 'nude weight was measured with scale with an accuracy of 10 g at admission time and seven days after admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diarrhea, lactose, milk, weight, acute.'], 'conditions': ['Acute Diarrhea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.', 'detailedDescription': 'Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. children with acute non-bloody diarrhea (≤ 2 weeks)\n2. mild to moderate dehydration\n\nExclusion Criteria:\n\n1. mucous bloody stools\n2. major systemic illness\n3. severe malnutrition (Weight for age \\<60% and Weight for height \\<70 %)\n4. history of antibiotics receiving'}, 'identificationModule': {'nctId': 'NCT01269892', 'briefTitle': 'Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Study of Nutritional Regime for Acute Diarrhea', 'orgStudyIdInfo': {'id': 'ASD-1213-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'lactose-free milk', 'description': 'it is kind of nutritional regime', 'interventionNames': ['Dietary Supplement: lactose-free milk']}, {'type': 'OTHER', 'label': 'conventional milk', 'description': 'it is kind of nutritional regime', 'interventionNames': ['Dietary Supplement: conventional milk']}], 'interventions': [{'name': 'lactose-free milk', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['nothing'], 'description': 'a milk without lactose', 'armGroupLabels': ['lactose-free milk']}, {'name': 'conventional milk', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['nothing'], 'description': 'a milk with lactose', 'armGroupLabels': ['conventional milk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Isfahan', 'state': 'Isfahan', 'country': 'Iran', 'facility': 'Al-zahra university hospital', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'Ali Gholamrezaei, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'MD,research comittee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Alireza Yousefy, Associate Professor of Medical Education', 'oldOrganization': 'Isfahan University of Medical Sciences'}}}}