Infant Formula Intolerance
Conditions
Keywords
infant formula
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.
Interventions
OTHERS-26 Gold
A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Days to 35 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant Gastrointestinal Symptom Questionnaire Composite Index Score | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Formula Intake volume | 6 weeks |
| Stool Consistency Score | 6 weeks |
| Baby Eating Behaviour Questionnaire Profile | 6 weeks |
| Infant Characteristics Questionnaire (ICQ) Profile | 6 weeks |
| Infant Toddler Quality of Life Profile | 6 weeks |
Other
| Measure | Time frame |
|---|---|
| Clinician-reported GI Adverse Event Profile | 6 weeks |
Countries
Philippines
Outcome results
None listed