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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant Formula Intolerance

Intervention / Treatment
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* Other: S-26 Gold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Healthy, full term, singleton infant Be between 28±7 days post-natal age Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts 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 Have sufficient command of Tagalog or English language to complete the informed consent and other study documents Are willing and able to fulfill the requirements of the study protocol Have reached the legal age of consent in the Philippines Able to be contacted by telephone throughout the study Exclusion Criteria: Infants who are receiving any amount of supplemental human milk Family history of siblings with documented cow's milk protein intolerance/allergy Conditions requiring infant feedings other than those specified in the protocol

Ages Eligible for Study
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Minimum Age: 21 Days
Maximum Age: 35 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-26 Gold<br>Standard Infant Formula containing enriched with alpha-lactalbumin | Other: S-26 Gold<br>* A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Gastrointestinal Symptom Questionnaire Composite Index Score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant formula