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

November 2, 2015 updated by: Nestlé

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
    • Muntinlupa City
      • Alabang, Muntinlupa City, Philippines, 1780
        • Asian Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant Gastrointestinal Symptom Questionnaire Composite Index Score
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Formula Intake volume
Time Frame: 6 weeks
6 weeks
Stool Consistency Score
Time Frame: 6 weeks
6 weeks
Infant Toddler Quality of Life Profile
Time Frame: 6 weeks
6 weeks
Baby Eating Behaviour Questionnaire Profile
Time Frame: 6 weeks
6 weeks
Infant Characteristics Questionnaire (ICQ) Profile
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Clinician-reported GI Adverse Event Profile
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Elvira M Estorninos, MD, Asian Hospital and Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14.23.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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