Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT06827405
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D043322', 'term': 'Lactase'}], 'ancestors': [{'id': 'D001616', 'term': 'beta-Galactosidase'}, {'id': 'D005696', 'term': 'Galactosidases'}, {'id': 'D006026', 'term': 'Glycoside Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-10', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of diarrhea', 'timeFrame': '5 days', 'description': 'It was labeled on the basis of frequency of stools ≤ 4 and consistency of stools ≤ 5 (Bristol Stool Chart, ideal range 3-5)'}, {'measure': 'Reduction in abdominal pain', 'timeFrame': '5 days', 'description': 'A score of ≤ 4, assessed on the basis of faces pain score revised chart (FPS-R), was considered as reduction in pain (a higher score indicating more severe pain)'}, {'measure': 'Lessening in bloating', 'timeFrame': '5 days', 'description': 'It was assessed on the basis of a decrease in the abdominal girth (≤ 1) at the umbilicus by a non- stretchable measuring tape'}, {'measure': 'Resolution of nausea/vomiting no perianal rash or only', 'timeFrame': '5 days', 'description': 'Decrease in the frequency of nausea/vomiting'}, {'measure': 'Resolution of perianal rash', 'timeFrame': '5 days', 'description': 'If no perianal rash or only erythema is seen'}], 'secondaryOutcomes': [{'measure': 'Treatment successful', 'timeFrame': '6 days', 'description': 'The secondary outcome was treatment success assessed on the basis of all 3 conditions fulfilled, i.e., diarrhea (frequency \\< 4 stools, consistency \\< 5) lasting less than 5 days, stool pH \\> 6, and hospital stays \\< 5 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Secondary Lactose Intolerance']}, 'descriptionModule': {'briefSummary': 'This study aimed to fill the gaps by comparing the effectiveness of oral lactase enzyme and lactose free formula in the management of secondary lactose intolerance in persistent and severe persistent diarrhea.', 'detailedDescription': 'Although it is well understood that oral lactase enzyme can play a pivotal role in hastening recovery due to secondary lactose intolerance in persistent diarrhea, there is limited local data available in this regard. If exogenous oral lactase enzyme is found to be more effective, it would help children receive uninterrupted milk and milk-based diet during the diarrheal episode, as the former would aid digestion and absorption of lactose, thus providing the necessary nutrients especially (calcium) and vitamins so vital in this period of rapid growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders\n* Aged 6-24 months\n* Presented with persistent or severe persistent diarrhea due to secondary lactose intolerance\n* Patients on formula or mixed feeding, or formula/cow/buffalo milk\n\nExclusion Criteria:\n\n* Severe acute malnutrition\n* Hemodynamic instability (shock)\n* Those on oral antibiotics or on excessive juices\n* With conditions of malabsorptive states (celiac disease, protein losing enteropathy, or irritable bowel syndrome)'}, 'identificationModule': {'nctId': 'NCT06827405', 'briefTitle': 'Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Comparison of the Effectiveness of Oral Lactase Enzyme and Lactose Free Formula in the Management of Secondary Lactose Intolerance in Persistent and Severe Persistent Diarrhea', 'orgStudyIdInfo': {'id': 'ZUHKARACHI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lactase enzyme group', 'description': 'In this group, 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, was added 5-30 minutes before feeding.', 'interventionNames': ['Dietary Supplement: Lactase enzyme']}, {'type': 'EXPERIMENTAL', 'label': 'Lactose-free formula feed group', 'description': 'In this group, lactose-free formula milk/diet was advised.', 'interventionNames': ['Dietary Supplement: Lactose-free formula feed']}], 'interventions': [{'name': 'Lactase enzyme', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients were given 5 drops of lactase enzyme (200 units lactase/drop)/ounce of milk, 5-30 minutes before feeding', 'armGroupLabels': ['Lactase enzyme group']}, {'name': 'Lactose-free formula feed', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients were advised lactose-free formula milk/diet.', 'armGroupLabels': ['Lactose-free formula feed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75620', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Ziauddin University Hospital, Kemari', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Fatima Ghayas, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamdard University Hospital, Karachi'}, {'name': 'Heena Ghayas, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ziauddin University Karachi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}