Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 6:19 AM
Study NCT ID:
NCT06158659
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2023-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D003139', 'term': 'Common Cold'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Two arms of participants will be assigned masked products (investigational formula and control formula) after randomization, while the participants of breastfeeding arm will not be assigned study products.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-11-26', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of flu and cold during the study', 'timeFrame': 'At the age of 12 months', 'description': 'Frequency of flu and cold that participants caught during the study, which has positive relationship with immunology outcomes.'}], 'secondaryOutcomes': [{'measure': 'Weight in grams', 'timeFrame': 'At the age of 15-28 days and 3, 6, 9, 12 months]', 'description': 'The weight measurement (gram) of the participant for each site visit'}, {'measure': 'Height in cm', 'timeFrame': 'At the age of 15-28 days and 3, 6, 9, 12 months', 'description': 'The height measurement (cm) of the participant for each site visit'}, {'measure': 'Head circumference in cm', 'timeFrame': 'At the age of 15-28 days and 3, 6, 9, 12 months', 'description': 'The head circumference measurement (cm) of the participant for each site visit'}, {'measure': 'Amount of formula intake in ml', 'timeFrame': 'At the age of 15-28 days and 3, 6, 9, 12 months', 'description': 'The 24-Hour dietary recall of Formula intake (amount in ml of study formula, any other infant formula or milk consumed) of the participant for each site visit'}, {'measure': 'Stool Characteristics Questionnaire', 'timeFrame': 'At the age of 15-28 days and 3, 6 months', 'description': 'The frequency of bowel movements and the rating score (0-5) of the stool consistency over the 24-hour period. The rating score of the stool consistency from the stool picture:\n\n0-No bowel movement;\n\n1. Hard- dry, hard pellets;\n2. Formed- definite shape, not dry;\n3. Soft-no definite shape, pasty;\n4. Unformed or seedy- no shape, some water or small lumps ;\n5. Waterly- no shape, mainly water where the score of 0-1 represents poor stool characteristics, while 2-5 represents fine stool characteristics.'}, {'measure': 'Medically-confirmed adverse events', 'timeFrame': 'baseline day to 12 months', 'description': 'The frequency of medically-confirmed adverse events occurred during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant formula', 'lactoferrin', 'HMO (Human Milk Oligosaccharides)', 'immunology'], 'conditions': ['Flu', 'Cold']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with Feihe investigational formula product containing Lactoferrin fortified with HMO. The main question it aims to answer is:\n\n\\- whether the immunity functions of participants in terms of frequency of catching flu and cold in the study product arm is significantly better than participants assigned in the other two arms.\n\n240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of catching flu and cold for each visit interval, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.\n\nResearchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing Lactoferrin fortified with HMO will improve immunity in newly born infants, along with physical development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newborn baby, study entry before weaning (within 28 days of birth)\n* Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).\n* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).\n* Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).\n* Signed informed consent obtained for infant's participation in the study.\n* Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.\n\nExclusion Criteria:\n\n* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.\n* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).\n* Evidence of growth problems or concern for growth.\n* Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.\n* Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.\n* Use of probiotics/prebiotics before the study."}, 'identificationModule': {'nctId': 'NCT06158659', 'briefTitle': 'Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heilongjiang Feihe Dairy Co. Ltd.'}, 'officialTitle': 'Improved Immunology Outcomes Associated With Feihe Lactoferrin Fortified With HMO in Infant Formula: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '22-SM-11-FEIHE-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feihe Investigational Formula', 'description': 'Feihe Investigational Formula\n\n1. With the highest lactoferrin content (more than blue)\n2. Contains 2 kinds of HMOs\n3. Double probiotic combination\n4. Comprehensive nutrition: OPO, DHA\\&ARA, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein', 'interventionNames': ['Dietary Supplement: Feihe Investigational Formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Formula', 'description': 'Control formula contains comparable macronutrients and micronutrients, but does not contain Lactoferrin fortified with HMO', 'interventionNames': ['Dietary Supplement: Control Formula']}, {'type': 'OTHER', 'label': 'Breastfeeding', 'description': 'breastmilk-feeding', 'interventionNames': ['Other: Breastfeeding']}], 'interventions': [{'name': 'Feihe Investigational Formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this arm will receive stage 1 and stage 2 Feihe investigational formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.', 'armGroupLabels': ['Feihe Investigational Formula']}, {'name': 'Control Formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this arm will receive stage 1 and stage 2 Control formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.', 'armGroupLabels': ['Control Formula']}, {'name': 'Breastfeeding', 'type': 'OTHER', 'description': 'Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.', 'armGroupLabels': ['Breastfeeding']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Jinhua Nanyuan Community Health Center', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Li Pu Community Hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Qiu Bin Community Hospital', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}], 'overallOfficials': [{'name': 'Weimin Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China National Center for Food Safety Risk Assessment Beijing, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heilongjiang Feihe Dairy Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}