Acceptability and GI Tolerance of an Alpha-lactalbumin-en... | NCT02431377

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

NCT02431377

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 3, 2015Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Infant Formula Intolerance

Interventions

S-26 Gold

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Apr 7, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

May 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
S-26 Gold	Experimental	Standard Infant Formula containing enriched with alpha-lactalbumin	Other: S-26 Gold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
S-26 Gold	Other	A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin	S-26 Gold

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Formula Intake volume		6 weeks
Stool Consistency Score		6 weeks
Infant Toddler Quality of Life Profile

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Days

Maximum Age

35 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elvira M Estorninos, MD	Asian Hospital and Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asian Hospital and Medical Center		Alabang	Muntinlupa City	1780	Philippines

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29884187	Derived	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.