Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-27 @ 5:58 AM
Study NCT ID:
NCT06312059
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goat or Cow Milk Based Infant Formula GMS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'RP Over stickered TP in blank packaging.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tolerability- Monitoring of stool consistency', 'timeFrame': '16 weeks', 'description': '• Stool characteristics (using BITSS) at baseline, and Weeks 2, 4, 8, 12, and 16'}, {'measure': 'Tolerability - fussiness', 'timeFrame': '16 weeks', 'description': '• Formula tolerance (using IGSQ) at baseline, and Weeks 2, 4, 8, 12, and 16'}, {'measure': 'Mean Daily Recumbent Length Gain', 'timeFrame': '16 weeks', 'description': 'Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in:\n\no mean daily recumbent length gain'}, {'measure': 'Mean Daily Head Circumference Gain', 'timeFrame': '16 weeks', 'description': 'Change from baseline through to Week 16 for infants fed TF1, infants fed TF2, and infants fed CF in:\n\no mean daily head circumference gain'}], 'primaryOutcomes': [{'measure': 'Growth as compared against WHO growth charts', 'timeFrame': '16 weeks', 'description': 'Mean daily weight gain for infants fed TF1 and infants fed TF2, each compared to infants fed CF, from baseline through to Week 16'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '16 weeks', 'description': 'Adverse Events reported over the 16-week study period (+4 days) for all groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Growth']}, 'descriptionModule': {'briefSummary': "This study is a non-inferiority, decentralized, randomized, double-blind, controlled clinical trial evaluating the growth, tolerance, and safety of a goat's-milk test infant formula (Test Formula 1; TF1) and a cow's-milk test infant formula (Test Formula 2; TF2), each compared to a cow's-milk infant formula commercially available in the United States (Control Formula; CF)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy term infants (37 to 42 weeks gestation at birth) from a singleton birth as assessed by the investigator\n2. Infants with a birth weight of \\>2500 g to \\<4500 g\n3. Infants ≤11 days of age at enrollment; birth constitutes Day 0\n4. Parent/legal guardian who has previously decided to exclusively feed infant formula and is willing to continue with formula feeding throughout the study\n\nExclusion Criteria:\n\nA participant who meets any of the following criteria will be excluded from participation in the study:\n\n1. Infant born with medical complications (e.g., neurological, cerebral palsy, etc.)\n2. Infant with failure to thrive, fever, any GI tract abnormalities (e.g., short gut, gastroesophageal reflux, etc.), any congenital illness or malformation that may affect infant feeding or normal growth\n3. Infant has been treated with prescription medications that in the Investigator's opinion could impact growth, gastrointestinal tolerance and/or development\n4. Infant that has received oral or parenteral antibiotics prior to enrollment\n5. Infant is taking and parent/legal guardian plans to continue (including over-the-counter medications, such as Mylicon® for gas), home remedies (such as juice for constipation), gastroesophageal reflux medications, herbal preparations, or rehydration fluids that, in the Investigator's opinion, might affect gastrointestinal tolerance. Use of the following are strongly discouraged for the duration of the trial:\n\n 1. Solid foods and juices\n 2. Vitamins and/mineral supplements, as the study product provided is nutritionally complete\n 3. Pre- and probiotics\n6. Infant with family history (biological siblings or parents) of confirmed milk protein allergy (Parent's lactose intolerance is not disqualifying)\n7. Parent(s)/Legal guardian(s) intent on feeding non-study formula, breastmilk, juices, or solid food during the study."}, 'identificationModule': {'nctId': 'NCT06312059', 'briefTitle': 'Goat or Cow Milk Based Infant Formula GMS', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kendal Nutricare Ltd'}, 'officialTitle': 'Growth Tolerance and Safety Study of Healthy Term Infants Consuming a Goat or Cow Milk Based Infant Formula', 'orgStudyIdInfo': {'id': 'KNC-GMS-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Market leader- Competitor Cow Milk based infant formula', 'description': 'Intervention with Competitor product currently in market- Control.', 'interventionNames': ['Other: Advance Infant Formula Powder']}, {'type': 'EXPERIMENTAL', 'label': 'Test product Cow Milk based infant formula', 'description': 'Intervention with Test product product - Test arm.', 'interventionNames': ['Other: "Kendamil Cow milk test product']}, {'type': 'EXPERIMENTAL', 'label': 'Test product Goat Milk based infant formula', 'description': 'Intervention with Test product product - Test arm.', 'interventionNames': ['Other: "Kendamil goat milk test product']}], 'interventions': [{'name': 'Advance Infant Formula Powder', 'type': 'OTHER', 'description': 'Sole source infant nutrition for the control arm.', 'armGroupLabels': ['Market leader- Competitor Cow Milk based infant formula']}, {'name': '"Kendamil Cow milk test product', 'type': 'OTHER', 'description': 'Sole source infant nutrition for the cow milk test arm.', 'armGroupLabels': ['Test product Cow Milk based infant formula']}, {'name': '"Kendamil goat milk test product', 'type': 'OTHER', 'description': 'Sole source infant nutrition for the goat milk test arm.', 'armGroupLabels': ['Test product Goat Milk based infant formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Parth Shah', 'role': 'CONTACT', 'email': 'parth.shah@obviohealth.com', 'phone': '513-571-5377'}], 'facility': 'ObvioHealth USA, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Luke Douglas', 'role': 'CONTACT', 'email': 'Luke.Douglas@KendalNutricare.com', 'phone': '+44 (0)7950211990'}, {'name': 'Will McMahon', 'role': 'CONTACT', 'email': 'Will.McMahon@kendamil.com', 'phone': '+44( 0)7484056316'}], 'overallOfficials': [{'name': 'Allan Soo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD, FAPCR ObvioHealth USA, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information to be shared with regulatory agencies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kendal Nutricare Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ObvioHealth', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}