Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
511 participants
OBSERVATIONAL
2011-07-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Marketed hypoallergenic infant formula containing a probiotic
Infant formula
Experimental 1
An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control
Infant formula
Experimental 2
An investigational hypoallergenic infant formula with a different protein content, without a probiotic
Infant formula
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Infant formula
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Term infant with birth weight of a minimum of 2500 grams
* Solely formula fed
* Signed Informed Consent and Protected Health Information
Exclusion Criteria
* Feeding difficulties or formula intolerance
12 Days
16 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mead Johnson Nutrition
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mead Johnson Nutrition
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Timothy Cooper, M.D.
Role: STUDY_DIRECTOR
Mead Johnson Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham Pediatric Associates
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, United States
Central Arkansas Pediatric Clinic
Benton, Arkansas, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States
Altamonte Pediatric Associates
Lake Mary, Florida, United States
Children's Medical Association
Plantation, Florida, United States
North Georgia Clinical Research Center/White's Pediatrics
Dalton, Georgia, United States
Deaconess Clinic
Newburgh, Indiana, United States
PTCU/Children and Youth Project
Louisville, Kentucky, United States
Owensboro Pediatrics
Owensboro, Kentucky, United States
Woburn Pediatric Associates
Woburn, Massachusetts, United States
Gretchen Swanson Center for Nutrition
Omaha, Nebraska, United States
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, United States
Innovis Health South University
Fargo, North Dakota, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, United States
Pediatric Associates of Fairfield, Inc
Fairfield, Ohio, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, United States
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, United States
The Jackson Clinic - North Jackson
Jackson, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Austin Diagnostic Clinic
Austin, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3383-1
Identifier Type: -
Identifier Source: org_study_id