Child Development, Diet, Healthy
Conditions
Keywords
Microbiota, Prebiota, Child´s health
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.
Detailed description
The fermentation of a novel prebiotic combination leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA).The efficacy of the prebiotic combination to improve toddler's digestive function will be addressed. The overall health will be assessed as a measure of reduced number of febrile days resulting in less days of absenteeism from daycare centers.
Interventions
DIETARY_SUPPLEMENTNew prebiotic follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
DIETARY_SUPPLEMENTStandard follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
Sponsors
Universitair Ziekenhuis Brussel
Beneo-Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Months to 36 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fever | Data collected continuously from enrollment until end of intervention (up to 90 days). | Number of febrile days (peak temperature of forehead at least 38.0°C) |
| Absenteeism | Data collected continuously from enrollment until end of intervention (up to 90 days). | Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beneficial colonization | Stool sample collected at baseline and after 90 days intervention period | Changes in fecal microbiota by 16S rRNA Sequencing |
| Stool consistency | Data collected continuously from enrollment until end of intervention (up to 90 days). | 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 |
| Stool frequency | Data collected continuously from enrollment until end of intervention (up to 90 days). | 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 |
| Caretaker´s absenteeism from work | Data collected continuously from enrollment until end of intervention (up to 90 days). | Number of work days missed by the parents |
Countries
Belgium
Contacts
Primary ContactStephan Theis, Dr
Backup ContactMaria Pudenz, Dr.
Outcome results
None listed