Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

Stopped early · Not applicable

Conditions studied: Gastrointestinal Microbiome

In brief

This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.

Key facts

Study ID

NCT04059666

Run by

Mead Johnson Nutrition

People needed

57

Starts

2019-03-05

Expected to finish

2022-02-02

Last updated by the study team

2022-08-25

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 7-18 days of age at Visit 1
• Singleton birth
• Gestational age of 37-42 weeks
• Birth weight of 2500 g (5 lbs 8 oz) or more
• Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent and use of PHI for infant and birth mother
• Receipt of three protocol-compliant Baseline stool samples
• Infants receiving formula:
• Exclusively receiving infant formula for at least 24 hours prior to randomization
• Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
• Infants receiving human milk:
• Mother has intention to exclusively provide mother's-own breast milk for the duration of the study

You may not qualify if…

• Caesarean delivery
• Infant consumption of donor milk prior to randomization/registration
• Maternal antibiotic use within 48 hours prior to or at time of delivery
• Maternal antibiotic use while providing mother's-own breast milk to infant
• Infant use of systemic antibiotics prior to randomization/registration
• Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
• Weight at Visit 1 is <95% of birth weight
• Infant use of probiotics
• Evidence of significant feeding difficulties
• Infant was born large for gestational age
• History of underlying metabolic or chronic disease or congenital malformation
• Infant is immunocompromised
• Infants receiving human milk:
• Consumption of infant formula from 1 day of age

Where it is running

• Birmingham Pediatric Associates — Birmingham, Alabama, United States
• Children's Research, LLC — Altamonte Springs, Florida, United States
• Owensboro Pediatrics — Owensboro, Kentucky, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Memphis & Shelby County Pediatric — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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