Prebiotic Effects in Healthy Toddlers

NCT05783141 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2024-09-19

No results posted yet for this study

Summary

The aim of this study is to demonstrate that a dietary supplementation with a novel prebiotic combination is safe, well tolerated and able to improve overall health of toddlers.

Conditions

  • Child Development
  • Diet, Healthy

Interventions

DIETARY_SUPPLEMENT

New prebiotic follow-on formula, randomly assigned to healthy toddlers

Standard follow-on formula administered orally

DIETARY_SUPPLEMENT

Standard follow-on formula, randomly assigned to healthy toddlers

Standard follow-on formula administered orally

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    collaborator OTHER
  • Beneo-Institute

    lead INDUSTRY

Principal Investigators

  • Yvan Vandenplas, Prof. · Universitair Ziekenhuis Brussel

  • Koen Huysentruyt, Prof. · Universitair Ziekenhuis Brussel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • Belgium

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 NCT05783141 on ClinicalTrials.gov