Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05046418
Status:
TERMINATED
Last Update Posted:
2025-02-26
First Post:
2021-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Synbiotics Cohort Study
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': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare use', 'timeFrame': '6 months', 'description': 'Data on the changes in healthcare use will be collected from medical records'}], 'secondaryOutcomes': [{'measure': 'Clinical impact and acceptability', 'timeFrame': '12 months post initiation of hypoallergenic formula containing synbiotics', 'description': 'Clinical outcomes related to CMA and parent/carer and infant acceptability will be assessed'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['synbiotics', 'paediatrics', 'gut microbiome'], 'conditions': ['Cows Milk Allergy']}, 'descriptionModule': {'briefSummary': "Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.", 'detailedDescription': "A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged \\<13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Months', 'minimumAge': '0 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Exclusively or partially formula fed infants with confirmed or suspected CMA who have been prescribed hypoallergenic formula containing synbiotics for the management of CMA as part of clinical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\<13 months\n* Confirmed or suspected CMA- based on healthcare professional (HCP) judgement\n* At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding\n* Recently prescribed a hypoallergenic formula containing synbiotics\n\nExclusion Criteria:\n\n* Exclusively breastfed infants\n* Primary lactose intolerance\n* Enterally fed infants\n* Premature infants (born \\<37 weeks) with a corrected age of less than 1 month\n* Infants with contraindications to the use of hyopallergenic formula containing synbiotics\n* Major hepatic or renal dysfunction\n* Investigator concern around the ability of family to comply with protocol and requirements of study'}, 'identificationModule': {'nctId': 'NCT05046418', 'briefTitle': 'Synbiotics Cohort Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia UK Ltd'}, 'officialTitle': "A Prospective, Observational, Cohort Study Investigating the Clinical Impact of Hypoallergenic Formulae With Synbiotics in Infants With Cow's Milk Allergy", 'orgStudyIdInfo': {'id': 'HAFSYN21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypoallergenic formula containing synbiotics', 'description': "Infants (aged \\<13 months) with cow's milk allergy (CMA) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of CMA.", 'interventionNames': ['Other: Hypoallergenic formula containing synbiotics']}], 'interventions': [{'name': 'Hypoallergenic formula containing synbiotics', 'type': 'OTHER', 'description': 'An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.', 'armGroupLabels': ['Hypoallergenic formula containing synbiotics']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poole', 'country': 'United Kingdom', 'facility': 'Adam Practice', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nutricia UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia UK Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}