Exploratory/Proof of Principle Microbiota Study
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
78 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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