Exploratory/Proof of Principle Microbiota Study

Completed · Not applicable

Conditions studied: Fecal Microbiota

In brief

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.

Key facts

Study ID

NCT02500563

Run by

Mead Johnson Nutrition

People needed

78

Starts

2015-07-01

Expected to finish

2017-07-01

Last updated by the study team

2017-07-28

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Midwest Children's Health Research Institue — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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