The Effect of Feeding Infant Formula With Enriched Protein Fractions
NCT ID: NCT02274883
Last Updated: 2017-09-01
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
451 participants
INTERVENTIONAL
2014-11-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Enriched Protein Fractions
This group is given Infant formula with enriched protein fractions.
Enriched Protein Fractions
Enriched protein fractions
Protein Fractions
This group is given Infant formula with protein fractions.
Protein Fractions
Protein fractions
Interventions
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Enriched Protein Fractions
Enriched protein fractions
Protein Fractions
Protein fractions
Eligibility Criteria
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Inclusion Criteria
* Exclusively formula-fed
* Singleton birth
* Gestational age of 37-42 weeks
* Birth weight of 2500g to 4000g
* Signed Informed Consent Form
Exclusion Criteria
* Congenital malformation
* Condition which is likely to interfere with food ingestion, normal growth, development and evaluation
* Evidence of feeding difficulties or intolerance
* Immunocompromised
* Head/brain disease/injury
10 Days
14 Days
ALL
Yes
Sponsors
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Shanghai Children's Medical Center
OTHER
Mead Johnson Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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John Colombo, Doctor
Role: STUDY_CHAIR
University of Kansas
Fei Li, Doctor
Role: STUDY_CHAIR
Shanghai Children's Medical Center
Bryan Liu, Doctor
Role: STUDY_DIRECTOR
Mead Johnson Nutrition
Locations
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Fuyang Fifth People's Hospital
Fuyang, Anhui, China
Fuyang Maternal and Child Health Institute
Fuyang, Anhui, China
Yinquan Maternal and Child Health Institute
Fuyang, Anhui, China
Countries
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References
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Chichlowski M, Bokulich N, Harris CL, Wampler JL, Li F, Berseth CL, Rudolph C, Wu SS. Effect of Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula on Gut Microbiome and Metabolome at 4 Months of Age. Curr Dev Nutr. 2021 Apr 2;5(5):nzab027. doi: 10.1093/cdn/nzab027. eCollection 2021 May.
Li F, Wu SS, Berseth CL, Harris CL, Richards JD, Wampler JL, Zhuang W, Cleghorn G, Rudolph CD, Liu B, Shaddy DJ, Colombo J. Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. J Pediatr. 2019 Dec;215:24-31.e8. doi: 10.1016/j.jpeds.2019.08.030. Epub 2019 Oct 24.
Other Identifiers
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6027
Identifier Type: -
Identifier Source: org_study_id
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