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Safety and Tolerance of a Partly Fermented Infant Formula With Prebiotic Oligosaccharides in Healthy Infants

NCT03476889 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2018-09-10

No results posted yet for this study

Summary

A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of a partly fermented infant formula containing prebiotic oligosaccharides in healthy term infants.

Conditions

  • Growth

Interventions

OTHER

Infant formula

Infants are randomized to one of two infant formulas from \<14 days of age to 17 weeks of age.

Sponsors & Collaborators

  • Nutricia Research

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-19
Primary Completion
2021-03-01
Completion
2021-03-01

Countries

  • Poland

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 NCT03476889 on ClinicalTrials.gov