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| Name | Class |
|---|---|
| Universitair Ziekenhuis Brussel | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental formula group | Experimental | Follow-on formula supplemented with a novel prebiotic combination |
|
| Control formula group | Placebo Comparator | Follow-on formula not supplemented |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New prebiotic follow-on formula, randomly assigned to healthy toddlers | Dietary Supplement | Standard follow-on formula administered orally |
|
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan Theis, Dr | Contact | +496359803287 | Stephan.Theis@beneo.com | |
| Maria Pudenz, Dr. | Contact | maria.pudenz@beneo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yvan Vandenplas, Prof. | Universitair Ziekenhuis Brussel | Principal Investigator |
| Koen Huysentruyt, Prof. | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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|
| Standard follow-on formula, randomly assigned to healthy toddlers | Dietary Supplement | Standard follow-on formula administered orally |
|
|
| 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). |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |