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Gastrointestinal Tolerance of Infant Formula | Clinical Trials | Clareo Health

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COMPLETEDNANCT02322138

Gastrointestinal Tolerance of Infant Formula

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

Lead sponsor: Abbott Nutrition•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Abbott Nutrition

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 23, 2015Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment131

Start dateJan 2015

Last updatedJul 23, 2015

Condition

Gastrointestinal Tolerance

Locations shown

W.O.M.B Watching Over Mothers and Babies

Tucson, Arizona

Clinical Research Advantage/Colorado Springs Health Partners

Colorado Springs, Colorado

Norwich Pediatric Group, PC

Norwich, Connecticut

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2015Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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