Exploratory/Proof of Principle Microbiota Study

Not Applicable

Completed

• Conditions: Fecal Microbiota
• Interventions: Other: Mother's own breast milk; Other: Amino acid based infant formula; Other: Extensively hydrolyzed casein infant formula

• Registration Number: NCT02500563
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Detailed Description

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Singleton, 1-7 days of age at registration or randomization
• Term infant with appropriate birth weight for gestational age
• Either solely formula fed or exclusively receiving mother's own breast milk
• Signed Informed Consent and Protected Health Information

Exclusion Criteria

• Caesarean delivery
• Infant was born from a mother with Type 1 diabetes
• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or history of formula or human milk intolerance
• Signs of acute infection of current use of antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mother's own breast milk	Mother's own breast milk	-
Amino acid based infant formula	Amino acid based infant formula	-
Extensively hydrolyzed casein infant formula	Extensively hydrolyzed casein infant formula	-

Primary Outcome Measures

Name	Time	Method
Fecal microbiota measured at each visit	8 weeks	Sequencing and composition of samples

Secondary Outcome Measures

Name	Time	Method
Body weight measured at each visit	8 weeks	Measurement collected with a calibrated infant scale
Parental recall of formula intake at each visit	8 weeks
Body length measured at each visit	8 weeks	Measurement collected with a standardized length board
Head circumference measured at each visit	8 weeks	Measurement collected with a standardized measuring tape
Serious adverse events collected throughout the study period	8 weeks
Stool collection at each visit	8 weeks	Composite measure of pH and short chain fatty acids

Trial Locations

Locations (1)

Midwest Children's Health Research Institue; 🇺🇸 Lincoln, Nebraska, United States