Gastrointestinal Tolerance of Infant Formula

Completed · Not applicable

Conditions studied: Gastrointestinal Tolerance

In brief

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Key facts

Study ID

NCT02322138

Run by

Abbott Nutrition

People needed

131

Starts

2015-01-01

Expected to finish

2015-06-01

Last updated by the study team

2015-07-23

Who can join

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

You may qualify if…

• Infant is judged to be in good health.
• Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
• Infant's birth weight was > 2490 g (\~5 lbs 8 oz.).
• Infant is between 0 and 8 days of age at enrollment.
• Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) 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…

• Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
• Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
• Mother intends to use a combination of breast and formula feeding.
• Participation in another study that has not been approved as a concomitant study by AN.

Where it is running

• W.O.M.B Watching Over Mothers and Babies — Tucson, Arizona, United States
• Clinical Research Advantage/Colorado Springs Health Partners — Colorado Springs, Colorado, United States
• Norwich Pediatric Group, PC — Norwich, Connecticut, United States
• SCORE Physician Alliance, LLC — St. Petersburg, Florida, United States
• Michael W. Simon, M.D., PSC — Nicholasville, Kentucky, United States
• Women's Clinic of Lincoln, PC. — Lincoln, Nebraska, United States
• White Oak Family Physicians DBA Asheboro Research Associates — Asheboro, North Carolina, United States
• Institute of Clinical Research — Mayfield Heights, Ohio, United States
• The Cleveland Pediatric Research Center, LLC — Middleburg Heights, Ohio, United States
• Tanner Memorial Clinic — Layton, Utah, United States

Full record on ClinicalTrials.gov

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