Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 12:42 AM
Study NCT ID:
NCT01109966
Status:
TERMINATED
Last Update Posted:
2017-05-08
First Post:
2010-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2010-03-29', 'studyFirstSubmitQcDate': '2010-04-22', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the development of oral tolerance in infants with IgE mediated CMA on control or test AAF.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To evaluate maturation of the GI immune system in IgE mediated CMA To confirm that the test formula is effective in the dietary management of CMA To assess frequency of other allergies', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergy', "Cow's Milk", 'Infants', 'Food Allergy'], 'conditions': ['Allergy', 'Food Allergy']}, 'referencesModule': {'references': [{'pmid': '33006765', 'type': 'DERIVED', 'citation': 'Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.", 'detailedDescription': "Infants with CMA cannot tolerate proteins contained in milk, although they are able to tolerate amino acids which are the 'building blocks' of proteins. Unlike standard infant formulas which are made from milk proteins, amino acid formulas (AAF) are made from nonallergenic aminoacids plus all the other nutrients required to support growth and development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants ≤ 8 months of age\n* Infants sensitised to cow's milk and diagnosed with IgE mediated cow's milk allergy confirmed by milk challenge or diagnosis of anaphylaxis to milk within the last 3 months\n\nExclusion Criteria:\n\n* Infants less than 2500 g at birth\n* Infants less than 37 weeks gestation\n* Infants with severe concurrent illness\n* Use of anti- histamines, systemic corticosteroids, systemic antibiotics or anti-mycotic drugs, and immuno-modulatory drugs\n* Infants consuming less than 500ml per day of their usual formula at study entry\n* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study"}, 'identificationModule': {'nctId': 'NCT01109966', 'briefTitle': "An Elimination Diet Using a New Amino Acid Based Formula: Immunological and Clinical Effects in Cow's Milk Allergy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)', 'orgStudyIdInfo': {'id': 'CT0140PAICE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amino acid based formula', 'description': 'Patients will be randomised to one of two arms:\n\nGroup I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula', 'interventionNames': ['Other: Special Medical Food']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'New amino acid based formula', 'description': 'Patients will be randomised to one of two arms:\n\nGroup I: receiving a new amino-acid based formula Group II: receiving a standard AAF formula', 'interventionNames': ['Other: Special Medical Food']}], 'interventions': [{'name': 'Special Medical Food', 'type': 'OTHER', 'otherNames': ['Amino acid based formula, Neocate LCP'], 'description': 'Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.\n\nInfants should typically consume the following amounts of formula during the study \\> 500mls/day up to 12 months of age \\> 400mls/day between 12 and 18 months of age \\> 300mls/day over 18 months of age.', 'armGroupLabels': ['Amino acid based formula']}, {'name': 'Special Medical Food', 'type': 'OTHER', 'otherNames': ['Amino acid based formula'], 'description': 'Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.\n\nInfants should typically consume the following amounts of formula during the study \\> 500mls/day up to 12 months of age \\> 400mls/day between 12 and 18 months of age \\> 300mls/day over 18 months of age.', 'armGroupLabels': ['New amino acid based formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': "l'hôpital Necker Enfants malades", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Hospital Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53115', 'city': 'Bonn', 'country': 'Germany', 'facility': 'St.-Marien-Hospital', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'PO30 5TG', 'city': 'Newport', 'state': 'Isle of Wight', 'country': 'United Kingdom', 'facility': "David Hyde Allergy Clinic - St. Mary's hospital", 'geoPoint': {'lat': 51.58774, 'lon': -2.99835}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "Evelina Children's Hospital - St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle general hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Kirsten Beyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Charité'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}