Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT05634603
Status:
UNKNOWN
Last Update Posted:
2022-12-02
First Post:
2022-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in diarrhea duration', 'timeFrame': '7 days', 'description': 'llness onset and last diarrhoeal stool (the number of days with 3 or more loose or watery stools)'}], 'secondaryOutcomes': [{'measure': 'Weight gain', 'timeFrame': '7 days'}, {'measure': 'Severity of diarrhea according to the modified Vesikari score', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diarrhea lactose-free diet'], 'conditions': ['Acute Gastroenteritis']}, 'referencesModule': {'references': [{'pmid': '24173771', 'type': 'RESULT', 'citation': 'MacGillivray S, Fahey T, McGuire W. Lactose avoidance for young children with acute diarrhoea. Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD005433. doi: 10.1002/14651858.CD005433.pub2.'}, {'pmid': '15279342', 'type': 'RESULT', 'citation': 'Simakachorn N, Tongpenyai Y, Tongtan O, Varavithya W. Randomized, double-blind clinical trial of a lactose-free and a lactose-containing formula in dietary management of acute childhood diarrhea. J Med Assoc Thai. 2004 Jun;87(6):641-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether lactose-free milk will change diarrhea duration and severity in formula-fed infants with acute gastroenteritis presenting to pediatric wards.', 'detailedDescription': 'More than 525 000 children die each year due to diarrheal disease, the second leading cause of death among children under five. Children from Asian countries, including Vietnamese children, frequently have lactose intolerance. In addition, gastroenteritis, specifically rotavirus-induced gastroenteritis, temporarily impairs lactase enzymes in the intestines. In a recent Cochrane review of 33 randomized and quasi-randomized trials, lactose-free diets reduced diarrhea among children younger than 5 years old. These trials, however, involved inpatients in middle-or high-income countries. Neither patient was from a developing country, where diarrheal diseases often cause significant morbidity and mortality. The purpose of this study is to determine whether lactose-free milk will change the duration and severity of diarrhea in Vietnamese infants with acute gastroenteritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 2- 24 months old on artificial milk formula\n* Acute diarrhea (3 or more loose or liquid stools per day)\n\nExclusion Criteria:\n\n* Used antibiotics within 3 days before admission\n* Breastfeeding\n* Severe dehydration, defined by a need of IV rehydration\n* Malnutrition (weight/height\\< -3SD)\n* Chronic underlying disease, immunocompromised condition or systemic infection'}, 'identificationModule': {'nctId': 'NCT05634603', 'briefTitle': 'Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants', 'organization': {'class': 'OTHER', 'fullName': 'The Women and Children Hospital of An Giang'}, 'officialTitle': 'Efficacy of Lactose-free Milk in Treating Acute Gastroenteritis in Infants: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'WCHAnGiang'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Lactose-free milk formula (Frisolac LF ®)', 'interventionNames': ['Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Regular infant milk formula', 'interventionNames': ['Dietary Supplement: Lactose-free milk formula (Frisolac LF ®)']}], 'interventions': [{'name': 'Lactose-free milk formula (Frisolac LF ®)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Following the initial rehydration phase, children were alternately assigned to receive 100 ml/kg/day of either lactose-free or lactose-containing formula', 'armGroupLabels': ['Intervention', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0292', 'city': 'Can Tho', 'status': 'RECRUITING', 'country': 'Vietnam', 'contacts': [{'name': 'Diep Ngoc Thai, doctor', 'role': 'CONTACT', 'email': 'ngocdiepthai41@gmail.com', 'phone': '0775838622', 'phoneExt': '084'}, {'name': 'Rang Ngoc Nguyen, Ph D', 'role': 'CONTACT', 'email': 'nguyenngocrang@gmail.com', 'phone': '0913106404', 'phoneExt': '084'}, {'name': 'Diep Ngoc Thai, doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Can Tho Children Hospital', 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Women and Children Hospital of An Giang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Can Tho University of Medicine and Pharmacy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Medicine and Pharmacy of Can Tho', 'investigatorFullName': 'Rang Nguyen', 'investigatorAffiliation': 'The Women and Children Hospital of An Giang'}}}}