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NCT Number: NCT05783141

Prebiotic Effects 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.

Recruiting

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Key information

Conditions

Child Development Diet, Healthy

Age range

10 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No legal guardian's command of any local language
  • 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)
  • Child is suffering from congenital or acquired immunodeficiency
  • Food allergies or intolerances
  • Child is currently breast-fed more than once daily
  • Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
  • 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.
  • Child is suffering from an infection at the time of pre examination or previous 7 days
  • Child is currently involved or will be involved in another clinical or food study
  • Child is not suitable for participation in the study according to the study personnel´s opinion

Treatment and study plan

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

Dietary Supplement

Standard follow-on formula administered orally

Other names: supplemented with prebiotics

Standard follow-on formula, randomly assigned to healthy toddlers

Dietary Supplement

Standard follow-on formula administered orally

Other names: not supplemented with prebiotics

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. Beneficial colonization

    Time frame: Stool sample collected at baseline and after 90 days intervention period

    Changes in fecal microbiota by 16S rRNA Sequencing

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Pudenz, Dr.

CONTACT

[email protected]

Stephan Theis, Dr

CONTACT

[email protected]

+496359803287

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Collaborators

  • Universitair Ziekenhuis Brussel

Registry information

Official study title

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

Acronym: PrebiKidz

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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