Prebiotic Effects in Healthy Toddlers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: New prebiotic follow-on formula, randomly assigned to healthy toddlers, Standard follow-on formula, randomly assigned to healthy toddlers.
- Who it may be relevant to
- Registry conditions: Child Development, Diet, Healthy. Basic parameters: 10 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers
Overview
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.
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.
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
Primary outcome measures
- Fever [Time frame: 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).]
Secondary outcome measures (4)
- Beneficial colonization [Time frame: 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).]
- Stool frequency [Time frame: 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- Universitair Ziekenhuis Brussel — Brussels
Identifiers
NCT: NCT05783141 · 22006n-mpz