NCT02670863

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

January 20, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

January 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

January 20, 2016

Last Update Submit

October 4, 2021

Conditions

Infant Term Birth

Outcome Measures

Primary Outcomes (2)

  • Growth

    weight gain velocity

    150 days

  • Stool Consistency Score

    150 days

Secondary Outcomes (5)

  • Weight

    150 days

  • Average Daily Stool Frequency

    150 days

  • Fecal Microbiota

    150 days

  • Fecal Markers

    150 days

  • Adverse Events

    150 days

Study Arms (2)

Experimental Infant Formula

EXPERIMENTAL

Experimental Infant Formula containing a prebiotic

Other: Experimental Infant Formula

Standard Infant Formula

ACTIVE COMPARATOR

Standard bovine milk-based term infant formula

Other: Standard Infant Formula

Interventions

Experimental Infant FormulaOTHER

Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum

Experimental Infant Formula
Standard Infant FormulaOTHER

Standard bovine milk-based term infant formula, fed ad libitum

Standard Infant Formula

Eligibility Criteria

Age21 Days - 26 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Written Informed Consent
  • Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
  • Infants whose parent(s)/LAR are willing and able to comply with study requirements
  • Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
  • Healthy term, singleton infant at birth
  • Between 21 to 26 days post-natal age at enrollment visit
  • Weight-for-length and head circumference-for-age z-scores \>/= - 3 and \</= +3 according to WHO Child Growth Standards
  • 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 study results
  • Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Hospital and Medical Center

City of Muntinlupa, 1780, Philippines

Location

Study Officials

  • Elvira M Estorninos, MD

    Asian Hospital and Medical Center

    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

January 20, 2016

First Posted

February 2, 2016

Study Start

January 21, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

October 11, 2021

Record last verified: 2021-10

Locations

PH(1)