Safety and Efficacy Study

Infant Term Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670863
• Other study ID #: 14.15.INF
• Status: Completed
• Phase: N/A
• Start date: January 21, 2016
• Est. completion date: May 2017

Study information

• Verified date: October 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 26 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Term Birth

Intervention

Other:
• Experimental Infant Formula
Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
• Standard Infant Formula
Standard bovine milk-based term infant formula, fed ad libitum

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	weight gain velocity	150 days
Primary	Stool Consistency Score		150 days
Secondary	Weight	weight in grams	150 days
Secondary	Average Daily Stool Frequency		150 days
Secondary	Fecal Microbiota		150 days
Secondary	Fecal Markers		150 days
Secondary	Adverse Events		150 days