Tolerance of Infants Fed a Hydrolysate Formula

Abbott

Status

Completed

Conditions

Gastrointestinal Tolerance

Treatments

Other: Hydrolysate Infant Formula 1

Other: Hydrolysate Infant Formula 2

Study type

Interventional

Funder types

Industry

Identifiers

AL30

Details and patient eligibility

About

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

Enrollment

51 patients

Sex

All

Ages

Under 14 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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