Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-29 @ 7:22 PM
Study NCT ID:
NCT06789068
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactose Intolerance in Infants With Gastrointestinal Disturbances
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007787', 'term': 'Lactose Intolerance'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of infants with LI and mis diagnosed as a cow milk protein allergy.', 'timeFrame': '4 weeks intervention', 'description': "Number of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lactose Intolerance']}, 'descriptionModule': {'briefSummary': "This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Artificially fed infants.\n* Presented with GIT symptoms such as vomiting, diarrhea, abdominal pain, discomfort and distention.\n* Cow's Milk-related Symptom Score (CoMiSS) of 12 or higher.\n\nExclusion Criteria:\n\n* Infants with positive family history of Cow's milk protein allergy CMPA.\n* Any allergic diseases.\n* History of anaphylaxis.\n* Atopic dermatitis, swelling of lips or eyelids, urticaria or wheezy chest."}, 'identificationModule': {'nctId': 'NCT06789068', 'briefTitle': 'Lactose Intolerance in Infants With Gastrointestinal Disturbances', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Lactose Intolerance in Infants With Gastrointestinal Disturbances', 'orgStudyIdInfo': {'id': 'FMASU MS 742/ 2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artificially fed infants', 'description': "Infants who presented by GIT symptoms and their Cow's Milk-related Symptom Score (CoMiSS) ≥ 12 who received lactose free diet regimen for 2 weeks then received then a regimen containing lactose, a tailored dietary plan was given to each participant, and it included lactose-containing formula and dairy based products like yogurt and cheese were included for infants over 6 months.", 'interventionNames': ['Other: lactose free regimen']}], 'interventions': [{'name': 'lactose free regimen', 'type': 'OTHER', 'description': 'lactose free formula and solid foods that lack lactose for infants above 6 months, ensuring adequate macro and micronutrients intake according to recommended daily allowances (RDA) for age and sex.', 'armGroupLabels': ['Artificially fed infants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pediatrics', 'investigatorFullName': 'Haya Essam Ibrahim', 'investigatorAffiliation': 'Ain Shams University'}}}}