Prebiotic Effects in Healthy Toddlers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-36
SponsorBeneo-Institute
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
New prebiotic follow-on formula, randomly assigned to healthy toddlers
Dietary supplementStandard follow-on formula administered orally
Standard follow-on formula, randomly assigned to healthy toddlers
Dietary supplementStandard follow-on formula administered orally
Treatment groups
342 Participants
are divided into 2 treatment groupsGroup A: Experimental formula groupExperimental treatment 1 intervention
Group B: Control formula groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fever
Number of febrile days (peak temperature of forehead at least 38.0°C)
Time frame
Data collected continuously from enrollment until end of intervention (up to 90 days).2
Absenteeism
Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment.
Time frame
Data collected continuously from enrollment until end of intervention (up to 90 days).Secondary outcomes
1
Beneficial colonization
Changes in fecal microbiota by 16S rRNA Sequencing
Time frame
Stool sample collected at baseline and after 90 days intervention period2
Stool consistency
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
Time frame
Data collected continuously from enrollment until end of intervention (up to 90 days).3
Stool frequency
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
Time frame
Data collected continuously from enrollment until end of intervention (up to 90 days).4
Caretaker´s absenteeism from work
Number of work days missed by the parents
Time frame
Data collected continuously from enrollment until end of intervention (up to 90 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beneo-Institute
Lead sponsor
Universitair Ziekenhuis Brussel
Collaborator
Source ClinicalTrials.gov