Actively Recruiting
Prebiotic Effects in Healthy Toddlers
Led by Beneo-Institute · Updated on 2024-09-19
342
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
B
Beneo-Institute
Lead Sponsor
U
Universitair Ziekenhuis Brussel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prebiotic Effects in Healthy Toddlers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Actively Recruiting
Research Team
S
Stephan Theis, Dr
CONTACT
M
Maria Pudenz, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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