Clinical trial NCT02431377: Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula
Official title: Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Formula Intolerance
Keywords: infant formula
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Gastrointestinal Symptom Questionnaire Composite Index Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Formula Intake volume
timeFrame: 6 weeks
measure: Stool Consistency Score
timeFrame: 6 weeks
measure: Infant Toddler Quality of Life Profile
timeFrame: 6 weeks
measure: Baby Eating Behaviour Questionnaire Profile
timeFrame: 6 weeks
measure: Infant Characteristics Questionnaire (ICQ) Profile
timeFrame: 6 weeks
Other outcomes:
measure: Clinician-reported GI Adverse Event Profile
timeFrame: 6 weeks
Locations:
city: Alabang
country: Philippines
facility: Asian Hospital and Medical Center
state: Muntinlupa City
Study officials:
affiliation: Asian Hospital and Medical Center
name: Elvira M Estorninos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volger S, Estorninos EM, Capeding MR, Lebumfacil J, Radler DR, Scott Parrott J, Rothpletz-Puglia P. Health-related quality of life, temperament, and eating behavior among formula-fed infants in the Philippines: a pilot study. Health Qual Life Outcomes. 2018 Jun 8;16(1):121. doi: 10.1186/s12955-018-0944-5.