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Acceptance Of A Partially-Hydrolyzed Infant Formula

CompletedNA

Sponsor: Mead Johnson Nutrition

Conditions: Stool

Interventions: Control, Investigational

Countries: United States

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Eligibility overview

Sex: ALL

Age: 28 Days to 300 Days

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Singleton 28-300 days of age at randomization
* Gestational age less than or equal to 35 weeks
* Receiving minimum 18oz infant formula in the 24hrs prior to randomization
* History of hard stools or stooling difficulty
* Signed informed consent and protected health information

Exclusion Criteria:

* Current diagnosis of cow's milk protein allergy or intolerance
* Use of extensively hydrolyzed or amino acid formula at randomization
* Any abdominal or gastrointestinal surgery prior to randomization
* History of underlying metabolic or chronic disease or congenital malformation
* Organic causes of constipation

Locations (11)

Birmingham, Alabama, United States
Dothan, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Evansville, Indiana, United States
Newburgh, Indiana, United States
Bardstown, Kentucky, United States
Owensboro, Kentucky, United States
Dayton, Ohio, United States
Charleston, South Carolina, United States
Longview, Texas, United States