Healthy Term Infants Fed Milk-Based Formulas

Abbott

Status and phase

Completed

Phase 3

Conditions

Healthy Term Infant

Treatments

Other: A powdered milk-based infant formula, standard fat blend

Other: Experimental powdered milk-based infant formula with an alternate fat blend

Study type

Interventional

Funder types

Industry

Identifiers

NCT01617889

AK88

Details and patient eligibility

About

The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.

Enrollment

17 patients

Sex

All

Ages

53 to 115 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infant is judged to be in good health.
Infant is singleton from a full term birth
Infant's birth weight was > 2490 g.
Infant is between 53 and 115 days of age
Infant is on infant formula and tolerating infant formula feedings
Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance

Exclusion criteria

Infant has received human milk within 7 days prior to SDay 1.

Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse

Infant has been treated with antibiotics within 5 days prior to SDay 1

Infant has received probiotics within 5 days prior to SDay 1.