Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-18 @ 2:01 AM
Study NCT ID:
NCT03769051
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2018-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016269', 'term': 'Milk Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-01', 'studyFirstSubmitDate': '2018-11-01', 'studyFirstSubmitQcDate': '2018-12-06', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative rate of open food challenge test', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'Negative rate =The subjects number with negative results of open food challenge test/total subject number with open food challenge test Unit:% Negative rate range: 0-100% High negative rate indicates the immune tolerance of CMPA infant using AAF'}], 'secondaryOutcomes': [{'measure': 'WAZ(weight for age Z score)', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'Z-scores of anthropometric parameters from baseline on weight=Average(The difference between the measured infant weight and the reference infant weight of the same age and sex/the reference infant weight standard deviation) The increase of WAZ indicated that AAF could promote growth and development.'}, {'measure': 'HAZ(height for age Z score)', 'timeFrame': 'From baseline until AAF feeding for 6 months', 'description': 'Z-scores of anthropometric parameters from baseline on height=Average(The difference between the measured infant height and the reference infant height of the same age and sex/the reference infant height standard deviation) The increase of HAZ indicated that AAF could promote growth and development.'}, {'measure': 'HCAZ(head circumference for age Z score)', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'Z-scores of anthropometric parameters from baseline on head circumference=Average(The difference between the measured infant head circumference and the reference infant head circumference of the same age and sex/the reference infant head circumference standard deviation) The increase of HCAZ indicated that AAF could promote growth and development.'}, {'measure': 'SCORAD score', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'An SCORAD evaluation scale was evaluated by the investigator at each visit'}, {'measure': 'Gastrointestinal symptom score', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'An Gastrointestinal symptom evaluation scale was evaluated by the investigator at each visit'}, {'measure': 'Respiratory symptom score', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'An Respiratory symptom evaluation scale was evaluated by the investigator at each visit'}, {'measure': 'Comfort symptom score', 'timeFrame': 'From baseline to AAF feeding for 6 months', 'description': 'An Comfort symptom evaluation scale was evaluated by the investigator at each visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Cow's Milk Protein allergy", 'Open Food Challenge test', 'Immune Tolerance', 'Amino Acid Formula'], 'conditions': ["Cow's Milk Protein Allergy"]}, 'descriptionModule': {'briefSummary': "The main purpose of this study was to observe the effect of amino acid formula on infants with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the allergic process in infants with cow's milk protein allergy and to explore the criteria for diagnosis and treatment.", 'detailedDescription': 'This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects. The suitable subject will be enrolled and there are seven visits through the 6-month study. Efficacy parameters are the positive incidence of open food challenge test, growth and development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Cow's milk protein allergy infants in 0\\~6 months", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 0 to 6 months;\n* Subject with cow's milk protein allergy (any clinical signs or symptoms of the skin, gastrointestinal tract, respiratory tract or comfortable tract)\n* Unable to breastfeed;\n* Vital signs are stable;\n* Legal guardian has signed the informed consent.\n\nExclusion Criteria:\n\n* Subject with congenital and hereditary metabolic diseases;\n* Digestive tract obstruction;\n* Subject with immunodeficiency diseases;\n* Subject who is allergic to known components of amino acid formula powder;\n* The investigator judges it is not suitable for the subject to participate in this study."}, 'identificationModule': {'nctId': 'NCT03769051', 'briefTitle': 'Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula', 'orgStudyIdInfo': {'id': '20180402 v1.3'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Juan Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Colleague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}