Effect of Formula on Infant Behavior

Completed · Not applicable

Conditions studied: Gastrointestinal Tolerance

In brief

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Key facts

Study ID

NCT02746016

Run by

Abbott Nutrition

People needed

69

Starts

2016-04-01

Expected to finish

2016-10-01

Last updated by the study team

2017-03-30

Who can join

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

You may qualify if…

• Subject is in good health as determined from subject's medical history by parent report
• Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
• Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
• Subject is between 7 and 42 days of age
• Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
• Infant is exclusively formula-fed at time of study entry
• 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
• Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

You may not qualify if…

• An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
• Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (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

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Southeastern Pediatric Associates — Dothan, Alabama, United States
• Watching Over Mothers and Babies — Tucson, Arizona, United States
• Norwich Pediatric Group, PC — Norwich, Connecticut, United States
• Florida Institute for Clinical Research, LLC — Orlando, Florida, United States
• Score Physician Alliance, LLC — St. Petersburg, Florida, United States
• Women's Clinic of Lincoln, PC — Lincoln, Nebraska, United States
• Institute of Clinical Research, LLC — Cleveland, Ohio, United States
• Aventiv Research — Grove City, Ohio, United States
• Coastal Pediatric Research — Charleston, South Carolina, United States
• DCOL Center for Clinical Research — Longview, Texas, United States
• Southwest Children's Research Associates, P.A. — San Antonio, Texas, United States
• Tanner Clinic — Layton, Utah, United States

Full record on ClinicalTrials.gov

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