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Starter Infant Formula With Synbiotics

NCT06073652 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-15

No results posted yet for this study

Summary

This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.

Conditions

  • Healthy Infants

Interventions

OTHER

Control 1st age starter infant formula

A standard bovine milk-based term infant formula.

OTHER

Experimental 1st age starter infant formula

Same content as Control formula plus supplemented with a HMO blend and a probiotic

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Maria Rosario Capeding, Dr · Asian Hospital Medical Center

  • Mitzi Trinidad Aseron, Dr · University of Perpetual Help Dalta Medical Center

  • Vinna Marie Quinones, Dr · University of the East Ramon Magsaysay Memorial Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Days
Max Age
35 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2024-08-14
Completion
2027-09-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06073652 on ClinicalTrials.gov