Prebiotic Effects in Healthy Toddlers (PrebiKidz)

July 26, 2023 updated by: Beneo-Institute

Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.

Study Type

Interventional

Enrollment (Estimated)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 3 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Child is healthy at the time of pre-examination
  2. Child is aged between 10-36 months and attends a day care center for the duration of the intervention
  3. Child attends a daycare center at the time of pre examination for at least 50%.
  4. Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
  5. Weight for height z-score >-2 and <2 SD based on Flemish growth charts
  6. Child and legal guardian are able and willing to follow the study instructions
  7. Child is suitable for participation in the study according to the investigator/ study personnel
  8. Informed written consent given by parent / legal guardian

Exclusion Criteria:

  1. No legal guardian's command of any local language
  2. Child with any chronic disorder or disease, e.g., defecation disorders (incl. Hirschsprung and celiac disease) metabolic or renal abnormalities as well as mental or psychomotor retardation (incl. child´s mental delay and hypotonia)
  3. Child is suffering from congenital or acquired immunodeficiency
  4. Food allergies or intolerances
  5. Child is currently breast-fed more than once daily
  6. Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
  7. Use of laxatives (4 weeks before intervention) as well as probiotic and prebiotic food supplements. Follow-on formula with L. Reuteri and/or GOS/FOS/HMO is allowed.
  8. Child is suffering from an infection at the time of pre examination or previous 7 days
  9. Child is currently involved or will be involved in another clinical or food study
  10. Child is not suitable for participation in the study according to the study personnel´s opinion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental formula group
Follow-on formula supplemented with a novel prebiotic combination
Dietary supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
Other Names:
  • supplemented with prebiotics
Placebo Comparator: Control formula group
Follow-on formula not supplemented
Dietary supplement: Standard follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
Other Names:
  • not supplemented with prebiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fever
Time Frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of febrile days (peak temperature of forehead at least 38.0°C)
Data collected continuously from enrollment until end of intervention (up to 90 days).
Absenteeism
Time Frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.
Data collected continuously from enrollment until end of intervention (up to 90 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beneficial colonization
Time Frame: Stool sample collected at baseline and after 90 days intervention period
Changes in fecal microbiota by 16S rRNA Sequencing
Stool sample collected at baseline and after 90 days intervention period
Stool consistency
Time Frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Hard, formed, soft and watery stools will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale
Data collected continuously from enrollment until end of intervention (up to 90 days).
Stool frequency
Time Frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of defecations will be assessed by the parents and day care centers in a continuous daily bowel diary using the Brussels Infant and Toddler Stool Scale
Data collected continuously from enrollment until end of intervention (up to 90 days).
Caretaker´s absenteeism from work
Time Frame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Number of work days missed by the parents
Data collected continuously from enrollment until end of intervention (up to 90 days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beneo-Institute

Collaborators

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Yvan Vandenplas, Prof., Universitair Ziekenhuis Brussel
  • Principal Investigator: Koen Huysentruyt, Prof., Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22006n-mpz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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