Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-13 @ 3:50 PM
Study NCT ID:
NCT07242508
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a New Infant Formula Composition on Gut Health in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'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': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bifidobacterium', 'timeFrame': 'From enrollment to the end of treatment at 10 weeks', 'description': 'Relative abundance of bifidobacterium from stool samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant', 'formula', 'microbiota', 'gut health', 'RCT'], 'conditions': ['Healthy Infants']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '0 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy, full term, infants with a birth weight between 2500-4500 grams\n* Parents independently from study decided to not breastfeed their infant\n* Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study\n* have read and voluntarily signed an informed consent form\n* parents are capable of completing study procedures required by the protocol\n\nExclusion Criteria:\n\n* suffering from any anatomic and/or physiologic condition that would interfere with normal growth, development or feeding\n* are required to take medications or supplements known to influence growth and development\n* have a maternal history with known adverse effects on the fetus and/or the newborn infant\n* have previous or current antibiotics use (antibiotics administered during delivery are permitted)\n* have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)\n* personal history of or parents/siblings diagnosed with cow's milk protein allergy or lactose intolerance\n* multiple birth\n* participation in another trial"}, 'identificationModule': {'nctId': 'NCT07242508', 'briefTitle': 'Efficacy of a New Infant Formula Composition on Gut Health in Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'FrieslandCampina'}, 'officialTitle': 'Efficacy of a New Infant Formula Composition on Gut Health in Infants: A Prospective Randomized Double-blind Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'ECCT2831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental infant formula', 'description': 'Infant formula with bioactive ingredients', 'interventionNames': ['Other: Infant Formula with bioactive ingredients']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control formula', 'description': 'Standard infant formula', 'interventionNames': ['Other: Infant Formula']}], 'interventions': [{'name': 'Infant Formula', 'type': 'OTHER', 'description': 'ad-libitum consumption of infant formula', 'armGroupLabels': ['Control formula']}, {'name': 'Infant Formula with bioactive ingredients', 'type': 'OTHER', 'description': 'ad-libitum consumption', 'armGroupLabels': ['Experimental infant formula']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FrieslandCampina', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}