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

Infant Formula Intolerance Clinical Trial

Official title:

Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431377
• Other study ID #: 14.23.INF
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: November 2, 2015
• Start date: April 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 35 Days

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infant Formula Intolerance

Intervention

Other:
• S-26 Gold
A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Alabang	Muntinlupa City

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician-reported GI Adverse Event Profile		6 weeks	Yes
Primary	Infant Gastrointestinal Symptom Questionnaire Composite Index Score		6 weeks	Yes
Secondary	Formula Intake volume		6 weeks	No
Secondary	Stool Consistency Score		6 weeks	No
Secondary	Infant Toddler Quality of Life Profile		6 weeks	No
Secondary	Baby Eating Behaviour Questionnaire Profile		6 weeks	No
Secondary	Infant Characteristics Questionnaire (ICQ) Profile		6 weeks	No