Clinical trial NCT05783141: Prebiotic Effects in Healthy Toddlers
Official title: Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Diet, Healthy
Keywords: Microbiota
Prebiota
Child´s health
Lead sponsor: Beneo-Institute
Sponsor class: INDUSTRY
Collaborators: name: Universitair Ziekenhuis Brussel
First posted: 2023-03-24
Enrollment: 342
Sex: ALL
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fever
timeFrame: Data collected continuously from enrollment until end of intervention (up to 90 days).
measure: Absenteeism
timeFrame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Secondary outcomes:
measure: Beneficial colonization
timeFrame: Stool sample collected at baseline and after 90 days intervention period
measure: Stool consistency
timeFrame: Data collected continuously from enrollment until end of intervention (up to 90 days).
measure: Stool frequency
timeFrame: Data collected continuously from enrollment until end of intervention (up to 90 days).
measure: Caretaker´s absenteeism from work
timeFrame: Data collected continuously from enrollment until end of intervention (up to 90 days).
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Yvan Vandenplas, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Koen Huysentruyt, Prof.
role: PRINCIPAL_INVESTIGATOR
References: