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OpenTrials
Completed

NCT Number: NCT02431377

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

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.

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Key information

Conditions

Infant Formula Intolerance

Age range

21 day–35 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Hospital and Medical Center

Alabang, Muntinlupa City, 1780, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S-26 Gold

Other

A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin

Primary outcomes

  1. Infant Gastrointestinal Symptom Questionnaire Composite Index Score

    Time frame: 6 weeks

Secondary outcomes

  1. Formula Intake volume

    Time frame: 6 weeks

  2. Stool Consistency Score

    Time frame: 6 weeks

  3. Infant Toddler Quality of Life Profile

    Time frame: 6 weeks

  4. Baby Eating Behaviour Questionnaire Profile

    Time frame: 6 weeks

  5. Infant Characteristics Questionnaire (ICQ) Profile

    Time frame: 6 weeks

Other outcomes

  1. Clinician-reported GI Adverse Event Profile

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 1, 2015
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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