NCT02431377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

April 7, 2015

Last Update Submit

November 2, 2015

Conditions

Infant Formula Intolerance

Keywords

infant formula

Outcome Measures

Primary Outcomes (1)

  • Infant Gastrointestinal Symptom Questionnaire Composite Index Score

    6 weeks

Secondary Outcomes (5)

  • Formula Intake volume

    6 weeks

  • Stool Consistency Score

    6 weeks

  • Infant Toddler Quality of Life Profile

    6 weeks

  • Baby Eating Behaviour Questionnaire Profile

    6 weeks

  • Infant Characteristics Questionnaire (ICQ) Profile

    6 weeks

Other Outcomes (1)

  • Clinician-reported GI Adverse Event Profile

    6 weeks

Study Arms (1)

S-26 Gold

EXPERIMENTAL

Standard Infant Formula containing enriched with alpha-lactalbumin

Other: S-26 Gold

Interventions

S-26 GoldOTHER

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

S-26 Gold

Eligibility Criteria

Age21 Days - 35 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Hospital and Medical Center

Alabang, Muntinlupa City, 1780, Philippines

Location

Related Publications (1)

  • 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.

    PMID: 29884187DERIVED

Study Officials

  • Elvira M Estorninos, MD

    Asian Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2015

First Posted

May 1, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-10

Locations

PH(1)