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

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ClinicalTrials.gov Identifier: NCT02431377
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Nestlé

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.

Condition or disease Intervention/treatment Phase
Infant Formula Intolerance Other: S-26 Gold Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study
Study Start Date : April 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Infant Gastrointestinal Symptom Questionnaire Composite Index Score [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Clinician-reported GI Adverse Event Profile [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431377


Locations
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Philippines
Asian Hospital and Medical Center
Alabang, Muntinlupa City, Philippines, 1780
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Elvira M Estorninos, MD Asian Hospital and Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02431377     History of Changes
Other Study ID Numbers: 14.23.INF
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: October 2015

Keywords provided by Nestlé:
infant formula