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

NCT04059666

TerminatedNA

Sponsor: Mead Johnson Nutrition

Conditions: Gastrointestinal Microbiome

Interventions: Investigational, Control

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 7 Days to 18 Days

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (5)

Birmingham, Alabama, United States
Altamonte Springs, Florida, United States
Owensboro, Kentucky, United States
Kingsport, Tennessee, United States
Memphis, Tennessee, United States