Prebiotic Effects in Healthy Toddlers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-blind, Randomized Placebo-controlled Trial Investigating Cumulative or Even Synergistic Effects of a Novel Prebiotic Combination in Healthy Toddlers

Conditions
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Child Development, Diet, Healthy

Intervention / Treatment
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* Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers
* Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers


Participation Criteria
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Eligibility Criteria
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Inclusion 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental formula group<br>Follow-on formula supplemented with a novel prebiotic combination | Dietary Supplement: New prebiotic follow-on formula, randomly assigned to healthy toddlers<br>* Standard follow-on formula administered orally<br>* Other names: supplemented with prebiotics;|
| Placebo Comparator: Control formula group<br>Follow-on formula not supplemented | Dietary Supplement: Standard follow-on formula, randomly assigned to healthy toddlers<br>* Standard follow-on formula administered orally<br>* Other names: not supplemented with prebiotics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever | Number of febrile days (peak temperature of forehead at least 38.0°C) | Data collected continuously from enrollment until end of intervention (up to 90 days). | 
| Absenteeism | Number of days of child´s absence from day care center due to infectious episodes or antibiotic treatment. | Data collected continuously from enrollment until end of intervention (up to 90 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beneficial colonization | Changes in fecal microbiota by 16S rRNA Sequencing | Stool sample collected at baseline and after 90 days intervention period | 
| 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 | Data collected continuously from enrollment until end of intervention (up to 90 days). | 
| 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 | Data collected continuously from enrollment until end of intervention (up to 90 days). | 
| Caretaker´s absenteeism from work | Number of work days missed by the parents | Data collected continuously from enrollment until end of intervention (up to 90 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Prebiota, Child´s health