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New treatment option for Child Development
Official title Prebiotic Effects in Healthy Toddlers
ClinicalTrials.gov ID: NCT05783141
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 36. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- 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)
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 months to 36 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.