Exploratory/Proof of Principle Microbiota Study
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 28, 2017
July 1, 2017
2 years
July 15, 2015
July 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Fecal microbiota measured at each visit
Sequencing and composition of samples
8 weeks
Secondary Outcomes (6)
Body weight measured at each visit
8 weeks
Body length measured at each visit
8 weeks
Head circumference measured at each visit
8 weeks
Parental recall of formula intake at each visit
8 weeks
Stool collection at each visit
8 weeks
- +1 more secondary outcomes
Study Arms (3)
Amino acid based infant formula
ACTIVE COMPARATORExtensively hydrolyzed casein infant formula
EXPERIMENTALMother's own breast milk
OTHERInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Midwest Children's Health Research Institue
Lincoln, Nebraska, 68504, United States
Related Publications (2)
Kok CR, Brabec B, Chichlowski M, Harris CL, Moore N, Wampler JL, Vanderhoof J, Rose D, Hutkins R. Stool microbiome, pH and short/branched chain fatty acids in infants receiving extensively hydrolyzed formula, amino acid formula, or human milk through two months of age. BMC Microbiol. 2020 Nov 9;20(1):337. doi: 10.1186/s12866-020-01991-5.
PMID: 33167908DERIVEDAmari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PMID: 33006765DERIVED
Study Officials
- STUDY DIRECTOR
Jon Vanderhoof, M.D.
Mead Johnson and Company
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 16, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
July 28, 2017
Record last verified: 2017-07