Skip to main content
OpenTrials
Completed

NCT Number: NCT02670863

Safety and Efficacy Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

21 day–26 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Hospital and Medical Center

City of Muntinlupa, 1780, Philippines

About this study

Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Experimental Infant Formula

Other

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

Standard Infant Formula

Other

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

Primary outcomes

  1. Growth

    Time frame: 150 days

    weight gain velocity

  2. Stool Consistency Score

    Time frame: 150 days

Secondary outcomes

  1. Weight

    Time frame: 150 days

    weight in grams

  2. Average Daily Stool Frequency

    Time frame: 150 days

  3. Fecal Microbiota

    Time frame: 150 days

  4. Fecal Markers

    Time frame: 150 days

  5. Adverse Events

    Time frame: 150 days

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2016
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.