Prebiotic Effects in Healthy Toddlers

Not Applicable

Not yet recruiting

• Conditions: Child Development; Diet, Healthy
• Interventions: Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers; Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers

• Registration Number: NCT05783141
• Lead Sponsor: Beneo-Institute

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.

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-24
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Study Start: 2023-09
• Primary Completion: 2024-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 342

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental formula group	New prebiotic follow-on formula, randomly assigned to healthy toddlers	Follow-on formula supplemented with a novel prebiotic combination
Control formula group	Standard follow-on formula, randomly assigned to healthy toddlers	Follow-on formula not supplemented

Primary Outcome Measures

Name	Time	Method
Absenteeism	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.
Fever	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)

Secondary Outcome Measures

Name	Time	Method
Stool frequency	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
Stool consistency	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
Beneficial colonization	Stool sample collected at baseline and after 90 days intervention period	Changes in fecal microbiota by 16S rRNA Sequencing
Caretaker´s absenteeism from work	Data collected continuously from enrollment until end of intervention (up to 90 days).	Number of work days missed by the parents

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium