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

Not Applicable

Terminated

• Conditions: Gastrointestinal Microbiome
• Interventions: Other: Investigational; Other: Control

• Registration Number: NCT04059666
• Lead Sponsor: Mead Johnson Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-05
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-08-14
• Study First Posted: 2019-08-16
• Primary Completion: 2022-02-02
• Study Completion: 2022-02-02
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational	Investigational	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
Comparison of stool microbiome between breast fed and formula fed babies	Over 60 days	Stool collection

Secondary Outcome Measures

Name	Time	Method
Stool molecules at each visit	Over 60 days	Stool sample
Stool color and consistency	3 times over 60 days	Color and consistency
Oral microbiome at each visit	Over 60 days	Buccal swab
24 hour recall of formula intake	2 times over 60 days	24 hour recall questionnaire
Medically confirmed adverse events	60 days	Medically confirmed adverse events
Stool pH	Over 60 days	pH

Trial Locations

Locations (5)

Children's Research, LLC; 🇺🇸 Altamonte Springs, Florida, United States

Owensboro Pediatrics; 🇺🇸 Owensboro, Kentucky, United States

Holston Medical Group; 🇺🇸 Kingsport, Tennessee, United States

Birmingham Pediatric Associates; 🇺🇸 Birmingham, Alabama, United States

Memphis & Shelby County Pediatric; 🇺🇸 Memphis, Tennessee, United States