Behavior of Infants Fed Formula Supplemented With Prebiotics

Completed · Not applicable

Conditions studied: Gastrointestinal Tolerance

In brief

To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.

Key facts

Study ID

NCT02757924

Run by

Abbott Nutrition

People needed

59

Starts

2016-05-01

Expected to finish

2017-05-02

Last updated by the study team

2017-06-19

Who can join

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

You may qualify if…

• Subject is judged to be in good health.
• Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
• Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
• Infant was identified by parents as very fussy or extremely fussy.
• Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
• Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

You may not qualify if…

• An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
• Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
• Subject participates in another study that has not been approved as a concomitant study.
• Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment.
• Subject has been treated with oral antibiotics within 7 days prior to study enrollment.
• Mother intends to use a combination of breast and formula feeding.

Where it is running

• Southeastern Pediatric Associates — Dothan, Alabama, United States
• Pensacola Research Consultants, Inc — Pensacola, Florida, United States
• Score Physician Alliance, LLC — St. Petersburg, Florida, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Aventiv Research — Grove City, Ohio, United States
• Coastal Pediatric Research — Charleston, South Carolina, United States
• Holston Medical Group — Bristol, Tennessee, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Southwest Children's Research Associates, P.A. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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