Clinical trial NCT04059666: Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Official title: Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Microbiome
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2019-08-16
Enrollment: 57
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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 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

Primary outcomes:
measure: Comparison of stool microbiome between breast fed and formula fed babies
timeFrame: Over 60 days
Secondary outcomes:
measure: Oral microbiome at each visit
timeFrame: Over 60 days
measure: Stool molecules at each visit
timeFrame: Over 60 days
measure: 24 hour recall of formula intake
timeFrame: 2 times over 60 days
measure: Stool color and consistency
timeFrame: 3 times over 60 days
measure: Medically confirmed adverse events
timeFrame: 60 days
measure: Stool pH
timeFrame: Over 60 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Altamonte Springs
country: United States
facility: Children's Research, LLC
state: Florida
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Memphis & Shelby County Pediatric
state: Tennessee
Study officials:
References: