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

Not Applicable

Completed

• Conditions: Infant Formula Intolerance
• Interventions: Other: S-26 Gold

• Registration Number: NCT02431377
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-05-01
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-26 Gold	S-26 Gold	Standard Infant Formula containing enriched with alpha-lactalbumin

Primary Outcome Measures

Name	Time	Method
Infant Gastrointestinal Symptom Questionnaire Composite Index Score	6 weeks

Secondary Outcome Measures

Name	Time	Method
Formula Intake volume	6 weeks
Stool Consistency Score	6 weeks
Infant Toddler Quality of Life Profile	6 weeks
Baby Eating Behaviour Questionnaire Profile	6 weeks
Infant Characteristics Questionnaire (ICQ) Profile	6 weeks

Trial Locations

Locations (1)

Asian Hospital and Medical Center; 🇵🇭 Alabang, Muntinlupa City, Philippines