Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06085118
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observatory on Cow's Milk Protein Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2031-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-10', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and proportion of symptoms', 'timeFrame': '5 years', 'description': 'Numbers and proportion of symptoms (cutaneous, gastrointestinal, respiratory...), and their evolution according to the different forms of cow protein allergy: immediate Immunoglobulin E mediated, delayed non-Immunoglobulin E mediated or mixed and acute food protein-induced enterocolitis syndrome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Allergy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed.\n\nThe Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.', 'detailedDescription': "This is a prospective, observational, descriptive, longitudinal, multicentric study aimed at describing a cohort of infants with a recently suspected or confirmed allergy to cow's milk protein, who were treated in outpatient and inpatient settings.\n\nThe recruitment of patients eligible for this observatory will be done via community medicine (private practices of pediatricians and general practitioners) as well as in hospitals throughout France."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The target population of our project will be infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed, newly diagnosed cow protein allergy requiring, according to the investigator's judgement, an initial prescription of the Pepticate® Syneo® advanced cow protein hydrolysate infant formula.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants up to and including 8 months (up to 8 months and 29 days).\n* Initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed.\n* Prescription of the substitution formula Pepticate® Syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding.\n* Authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family.\n* Membership of the social security system.\n\nExclusion Criteria:\n\n* Infants who have already received partial or total replacement infant formula (regardless of the type of infant formula).\n* Contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of Pepticate® Syneo®.\n* Diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset.\n* The child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision).\n* The legal representative is unable to understand the study protocol."}, 'identificationModule': {'nctId': 'NCT06085118', 'acronym': 'OLAF', 'briefTitle': "Observatory on Cow's Milk Protein Allergy", 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Nutrition Clinique'}, 'officialTitle': "Prospective National Observatory for Cow's Milk Protein Allergy.", 'orgStudyIdInfo': {'id': '2023-A01285-40'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed cow protein allergy.', 'interventionNames': ['Other: Pepticate® Syneo®']}], 'interventions': [{'name': 'Pepticate® Syneo®', 'type': 'OTHER', 'description': 'Introduction of the nutritional treatment Pepticate® Syneo® (high protein hydrolysate), as a foodstuff for special medical purposes (product already available on the market).', 'armGroupLabels': ['Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06300', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Phu My TRAN, MD', 'role': 'CONTACT', 'phone': '492040274', 'phoneExt': '+33'}], 'facility': 'Cabinet du Dr Phu My TRAN', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75012', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anaïs LEMOINE, MD', 'role': 'CONTACT'}], 'facility': 'Hôpital Trousseau - APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Line JOUANNIC', 'role': 'CONTACT', 'email': 'line.samier@danone.com', 'phone': '603883762', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Nutrition Clinique', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}