Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula

Nestlé

Status: Completed

Conditions: Infant Formula Intolerance

Treatments: Other: S-26 Gold

Study type: Interventional

Funder types: Industry

Identifiers

NCT02431377

14.23.INF

Details and patient eligibility

About

A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.

Full description

The purpose of this study is to examine the tolerable and acceptability of an infant formula with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance, and eating behaviors.

Enrollment: 40 patients

Sex: All

Ages: 21 to 35 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Written informed consent
2. Healthy, full term, singleton infant
3. Be between 28±7 days post-natal age
4. Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts
5. Infants must be exclusively consuming and tolerating a cow's milk infant formula for a minimum of 3 consecutive days and parent(s)/LAR must have previously made the decision to continue to exclusively formula feed
6. Have sufficient command of Tagalog or English language to complete the informed consent and other study documents
7. Are willing and able to fulfill the requirements of the study protocol
8. Have reached the legal age of consent in the Philippines
9. Able to be contacted by telephone throughout the study

Exclusion criteria

1. Infants who are receiving any amount of supplemental human milk
2. Family history of siblings with documented cow's milk protein intolerance/allergy
3. Conditions requiring infant feedings other than those specified in the protocol

Trial design

40 participants in 1 patient group

S-26 Gold

Experimental group

Description:

Standard Infant Formula containing enriched with alpha-lactalbumin

Treatment:

Other: S-26 Gold