PrebiKidz: Prebiotic Effects in Healthy Toddlers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental formula group Follow-on formula supplemented with a novel prebiotic combination |
Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
Other Names:
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| Placebo Comparator: Control formula group Follow-on formula not supplemented |
Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers
Standard follow-on formula administered orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Child is healthy at the time of pre-examination
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Child is aged between 10-36 months and attends a day care center for the duration of the intervention
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Child attends a daycare center at the time of pre examination for at least 50%.
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Child presents a normal defecation characteristic (according to Brussels Infant and Toddler Stool scale)
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Weight for height z-score >-2 and <2 SD based on Flemish growth charts
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Child and legal guardian are able and willing to follow the study instructions
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Child is suitable for participation in the study according to the investigator/ study personnel
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Informed written consent given by parent / legal guardian
Exclusion Criteria:
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No legal guardian's command of any local language
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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)
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Child is suffering from congenital or acquired immunodeficiency
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Food allergies or intolerances
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Child is currently breast-fed more than once daily
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Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
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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.
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Child is suffering from an infection at the time of pre examination or previous 7 days
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Child is currently involved or will be involved in another clinical or food study
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Child is not suitable for participation in the study according to the study personnel´s opinion
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beneo-Institute
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Yvan Vandenplas, Prof., Universitair Ziekenhuis Brussel
- Principal Investigator: Koen Huysentruyt, Prof., Universitair Ziekenhuis Brussel
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22006n-mpz