| NCT ID | NCT05783141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beneo-Institute |
| Condition | Child Development |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 342 participants in total. It began in 2023-10-01 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Yvan Vandenplas, Prof.
PRINCIPAL INVESTIGATOR
Universitair Ziekenhuis Brussel
Frequently Asked Questions
Who can join the NCT05783141 clinical trial?
This trial is open to participants of all sexes, aged 10 Months or older, up to 36 Months, studying Child Development. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05783141 currently recruiting?
Yes, NCT05783141 is actively recruiting participants. Contact the research team at Stephan.Theis@beneo.com for enrollment information.
Where is the NCT05783141 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT05783141 clinical trial?
NCT05783141 is sponsored by Beneo-Institute. The principal investigator is Yvan Vandenplas, Prof. at Universitair Ziekenhuis Brussel. The trial plans to enroll 342 participants.