Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method

Abbott Nutrition5 sites in 1 country51 target enrollmentAugust 28, 2018

Overview

This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

Registry

clinicaltrials.gov

Start Date

August 28, 2018

End Date

November 23, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Subject is judged to be in good health
•Singleton from a full-term birth
•Birth weight was \> or = to 2490 g
•Between 0 and 14 days of age at enrollment
•Parent(s) confirm their intention to feed their infant the assigned 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
•Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

•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, 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 an allergy or intolerance to any ingredient in the study product
•Subject has been treated with antibiotics within 2 weeks prior to enrollment