Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT03925558
Status:
COMPLETED
Last Update Posted:
2019-04-25
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance of a Probiotic Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-23', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-23', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight (g)', 'timeFrame': '8 weeks'}, {'measure': 'Body length (cm)', 'timeFrame': '8 weeks'}, {'measure': 'Head circumference (cm)', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues']}, 'descriptionModule': {'briefSummary': 'Evaluate the tolerance of a probiotic formula in infants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '95 Days', 'minimumAge': '3 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Full term healthy infant aged 3-95 days\n\nExclusion Criteria:\n\n* Prematurity\n* Low birth weight\n* Congenital anomalies\n* Chronic disease\n* Failure to thrive\n* Allergy or atopic disease\n* Recent exposure to antibiotics'}, 'identificationModule': {'nctId': 'NCT03925558', 'briefTitle': 'Tolerance of a Probiotic Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Probi AB'}, 'officialTitle': 'Tolerance of a Probiotic Formula Containing Lactobacilli', 'orgStudyIdInfo': {'id': 'ProTolerance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Probiotic formula', 'description': 'Lactobacillus strains', 'interventionNames': ['Dietary Supplement: Probiotics']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo formula', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotics', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Probiotic formula']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo formula']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Probi AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}