Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT06137235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, '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': 456}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight', 'timeFrame': 'until age of 6 months', 'description': 'weight for age, compared to WHO growth curve, for test group only'}, {'measure': 'infection-related morbidity episodes, parent-reported', 'timeFrame': '6 - 12 months of age', 'description': 'number of parental-reported respiratory and gut infection-related symptoms, compared between test and control group'}], 'secondaryOutcomes': [{'measure': 'weight', 'timeFrame': 'until the age of 6 months', 'description': 'weight for age, compared to WHO growth curve, for control group'}, {'measure': 'length', 'timeFrame': 'until the age of 6 months', 'description': 'length in cm'}, {'measure': 'head circumference', 'timeFrame': 'until the age of 6 months', 'description': 'head circumference in cm'}, {'measure': 'BMI', 'timeFrame': 'until the age of 6 months', 'description': 'BMI in kg/m2'}, {'measure': 'product tolerance: GI comfort', 'timeFrame': 'until the age of 6 months', 'description': 'GI comfort questionnaire'}, {'measure': 'product tolerance: stool frequency and consistency', 'timeFrame': 'until the age of 6 months', 'description': 'stool frequency and consistency questionnaire'}, {'measure': 'product tolerance: product intake', 'timeFrame': 'until the age of 6 months', 'description': 'product intake (ml/feeding, ml/day)'}, {'measure': 'Duration of infection-related episodes', 'timeFrame': '6 - 12 months of age', 'description': 'duration of parental-reported respiratory and gut infection-related symptoms in summed days'}, {'measure': 'infection-related morbidity episodes, physician-diagnosed', 'timeFrame': '6 - 12 months of age', 'description': 'number of physician-diagnosed respiratory and gut infection-related symptoms'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant nutrition', 'growth', 'gut comfort', 'product tolerance', 'infections'], 'conditions': ['Growth', 'Infections']}, 'descriptionModule': {'briefSummary': 'In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF', 'detailedDescription': 'In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF, until the age of 1y. 456 healthy term infants who are exclusively formula-fed will be included \\<2mo of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '5 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Full-term infants\n* Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g\n* Boys and girls\n* Apparently healthy at birth and screening\n* Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards\n* Age at enrolment: ≤60 days of age\n* If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion\n* If 1 month \\< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2\n* Being available for follow up until the age of 12 months\n* Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years\n\nExclusion Criteria:\n\n* Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))\n* Incapability of parents to comply with the study protocol\n* Illiterate parents (i.e. not able to read and write in local language)\n* Participation in another clinical trial\n* Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months\n* Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion"}, 'identificationModule': {'nctId': 'NCT06137235', 'briefTitle': 'Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'FrieslandCampina'}, 'officialTitle': 'A Randomized, Controlled, Double-blind Parallel Group Trial to Study the Effects of an Infant Formula and a follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections in Healthy Term Infants', 'orgStudyIdInfo': {'id': 'Armadillo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test formula', 'description': 'infant formula and follow-on formula with bioactive ingredients', 'interventionNames': ['Other: cows milk infant formula and follow-on formula with bioactive ingredients']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control formula', 'description': 'standard infant formula and follow-on formula', 'interventionNames': ['Other: standard cows milk infant formula and follow-on formula']}], 'interventions': [{'name': 'cows milk infant formula and follow-on formula with bioactive ingredients', 'type': 'OTHER', 'description': 'infant formula and follow-on formula with bioactive ingredients', 'armGroupLabels': ['test formula']}, {'name': 'standard cows milk infant formula and follow-on formula', 'type': 'OTHER', 'description': 'standard cows milk infant formula and follow-on formula', 'armGroupLabels': ['control formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'country': 'Greece', 'facility': 'Harokopio University', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'International Hellenic University', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Trikala', 'country': 'Greece', 'facility': 'University of Thessaly', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}], 'overallOfficials': [{'name': 'Yannis Manios, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harokopio University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FrieslandCampina', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}