Acceptance Of A Partially-Hydrolyzed Infant Formula

Completed · Not applicable

Conditions studied: Stool

In brief

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

Key facts

Study ID

NCT03223792

Run by

Mead Johnson Nutrition

People needed

100

Starts

2017-08-21

Expected to finish

2018-12-31

Last updated by the study team

2019-01-09

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham Pediatric Associates — Birmingham, Alabama, United States
• Southeastern Pediatric Associates — Dothan, Alabama, United States
• Northwest Arkansas Pediatric Clinic — Fayetteville, Arkansas, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Deaconess Clinical Research — Evansville, Indiana, United States
• Deaconess Clinic — Newburgh, Indiana, United States
• Kentucky Pediatrics/Adult Research — Bardstown, Kentucky, United States
• Owensboro Pediatrics — Owensboro, Kentucky, United States
• Ohio Pediatric Research Association — Dayton, Ohio, United States
• Coastal Pediatric Research — Charleston, South Carolina, United States
• DCOL Center for Clinical Research — Longview, Texas, United States

Full record on ClinicalTrials.gov

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