Safety and Efficacy Study

Not Applicable

Completed

• Conditions: Infant Term Birth
• Interventions: Other: Experimental Infant Formula; Other: Standard Infant Formula

• Registration Number: NCT02670863
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-01-20
• Study Start: 2016-01-21
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Primary Completion: 2017-03
• Study Completion: 2017-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Infant Formula	Experimental Infant Formula	Experimental Infant Formula containing a prebiotic
Standard Infant Formula	Standard Infant Formula	Standard bovine milk-based term infant formula

Primary Outcome Measures

Name	Time	Method
Stool Consistency Score	150 days
Growth	150 days	weight gain velocity

Secondary Outcome Measures

Name	Time	Method
Weight	150 days	weight in grams
Average Daily Stool Frequency	150 days
Fecal Microbiota	150 days
Fecal Markers	150 days
Adverse Events	150 days

Trial Locations

Locations (1)

Asian Hospital and Medical Center; 🇵🇭 Muntinlupa, Philippines