Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
179 participants
INTERVENTIONAL
2022-04-10
2023-12-25
Brief Summary
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Participants：144 healthy term infants aged less than 30 days at entry to study. Study Design: A open-label,parallel, controlled trial.
Arms, Groups, and Intervention: (1) Breast milk-fed group: fed with human breast milk; (2) Breast Milk Simulated Formula Group：fed with breast milk simulated infant formula (Ruibuen®Kieember, Phase I); (3) Traditional Formula Group: fed with traditional infant formula (Ruibuen®Yashili, Phase I).
Intervention Duration: 90 days.
Visits: 1month and 3month old.
Outcome measures: (1)Biochemical detection of feces (total fat, fatty acids, calcium, nitrogen);(2)Stool characteristics (frequency, color, volume, and stool consistency);(3)Anthropometric parameters (body length, body weight, and head circumferences);(4)Temperament and adaptive behavior;(5)Gut microbiota;(6)General health and wellbeing;(7)concomitant medications and adverse events.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Breast Milk-Fed Group
The infants will be breastfed during the study.
Breast milk
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
Breast Milk Simulated Formula Group
Kieember Infant formula, Ruibuen®: Infants will be fed Kieember infant formula(Phase I) from baseline (1 month old) to 3 month old.
Kieember Infant formula, Ruibuen®
Kieember Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by (1) OPO structured lipid of the third generation; and (2) Breast Milk Simulated complete structured lipid UPU. It was produced by Yashili New Zealand Dairy Co., Limited
Traditional Formula Group
Yashili Infant formula, Ruibuen®: Infants will be fed Yashili infant formula (Phase I) from baseline (1 month old) to 3 month old.
Yashili Infant formula, Ruibuen®
Yashili Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by(1) lactoferrin and(2) lutein . It was produced by Yashili International Holdings Ltd.,China
Interventions
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Breast milk
Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
Kieember Infant formula, Ruibuen®
Kieember Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by (1) OPO structured lipid of the third generation; and (2) Breast Milk Simulated complete structured lipid UPU. It was produced by Yashili New Zealand Dairy Co., Limited
Yashili Infant formula, Ruibuen®
Yashili Infant formula, Ruibuen®: a type of Phase I infant formula for 0-6 month infants, with a trademark of Ruibuen®. The formula is characterized by(1) lactoferrin and(2) lutein . It was produced by Yashili International Holdings Ltd.,China
Eligibility Criteria
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Inclusion Criteria
* Birth weight: 2500-4000g (appropriate for gestational age)
* The infant is in good health and Apgar after 5 minutes \>7
* The mother had unequivocally decided not to breastfeed (for formula fed infants) or to breastfeed (for human milk fed infants)
* age at the enrollment: less than 30 days
Exclusion Criteria
* The infant is born with a congenital malformation or chromosome abnormality with a clinical significance
* The infant suffers from a disease requiring mechanical ventilation or medication in the first week of life (not including applying phototherapy of blue to cure neonatal jaundice)
* The infant whose feeding or normal metabolism is affected by any suspected or unknown metabolic factors or physical limitations
* The infant has been breastfed for more than 2 weeks (for formula fed infants)
* Twins or multiple births
0 Days
30 Days
ALL
Yes
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Huilian Zhu
Professor
Locations
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Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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MN-2022-01
Identifier Type: -
Identifier Source: org_study_id