NCT03710551

Brief Summary

The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2019

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

October 16, 2018

Last Update Submit

February 18, 2021

Conditions

Infant Term Birth

Outcome Measures

Primary Outcomes (1)

  • Stool Consistency Score

    3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days. A validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools. Stool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate. the percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period.

    Study Day 57, corresponding to infant age of 78-85 days

Secondary Outcomes (4)

  • GI Tolerance

    which corresponds to infant age of 21-28, 43-50, and 78-85 days.

  • Changes in Weight from baseline to 57 days

    Study Day 57, corresponding to infant age of 78-85 days

  • Changes in Length from baseline to 57 days

    Study Day 57, corresponding to infant age of 78-85 days

  • Changes in Head Circumference from baseline to 57 days

    Study Day 57, corresponding to infant age of 78-85 days

Study Arms (2)

Experimental Infant Formula

EXPERIMENTAL

Experimental Infant Formula with a new fat blend plus L. reuteri

Other: Experimental Infant Formula

Standard Infant Formula

ACTIVE COMPARATOR

Standard bovine milk-based infant formula.

Other: Standard Infant Formula

Interventions

Experimental Infant FormulaOTHER

Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum

Experimental Infant Formula
Standard Infant FormulaOTHER

Standard bovine milk-based infant formula, fed ad libitum

Standard Infant Formula

Eligibility Criteria

Age21 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Written Informed Consent
  • Infants whose parents/LAR have reached the legal age of majority in the Philippines
  • Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
  • Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
  • Healthy term, singleton infant at birth
  • Between 21 to 28 days post-natal age at enrollment visit
  • Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
  • Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

You may not qualify if:

  • Infants with conditions requiring infant feedings other than those specified in the protocol
  • Infants receiving complementary foods or liquids
  • Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
  • Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Hospital and Medical Center

City of Muntinlupa, 1781, Philippines

Location

Study Officials

  • Elvira M Estorninos

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 18, 2018

Study Start

September 26, 2018

Primary Completion

June 21, 2019

Study Completion

July 21, 2019

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

PH(1)