Effects of a new prebiotic on the health of toddlers

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

This study is testing a new prebiotic formula to see if it can improve gut health and overall well-being in healthy toddlers aged 10 to 36 months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: 10 Months to 36 Months
• Sex: All
• Sponsor: Beneo-Institute (Industry-sponsored)
• Locations: 1 site (Brussels)
• Trial ID: NCT05783141 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and tolerability of a novel prebiotic combination in healthy toddlers aged 10 to 36 months. The intervention involves randomly assigning participants to receive either the new prebiotic follow-on formula or a standard follow-on formula. The study will assess the impact of the prebiotic on gut microbiota composition and overall health, measured by the reduction in febrile days and absenteeism from daycare. The goal is to demonstrate improvements in digestive function and overall health outcomes for toddlers.

Who should consider this trial

Good fit: Ideal candidates are healthy toddlers aged 10 to 36 months who attend daycare and have normal defecation characteristics.

Not a fit: Patients with chronic disorders, metabolic or renal abnormalities, or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved digestive health and reduced illness in toddlers, enhancing their overall well-being.

How similar studies have performed: Other studies have shown promising results with prebiotic interventions in improving gut health, suggesting potential success for this approach.

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

Where this trial is running

Brussels

• Universitair Ziekenhuis Brussel — Brussels, Belgium (Recruiting)

Study contacts

• Principal investigator: Yvan Vandenplas, Prof. — Universitair Ziekenhuis Brussel
• Study coordinator: Stephan Theis, Dr

Conditions Child Development; Diet, Healthy; Microbiota; Prebiota; Child´s health