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| Name | Class |
|---|---|
| Mitacs | INDUSTRY |
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In adults, probiotics have been shown to have no effect on the microbial composition and the beneficial effects are only transient. However, the gut microbiota of young children is less stable and more impressionable. The aim of this study is to examine the effects of probiotics on the developing microbiota in early life and to determine whether a young child's microbiota may be less resilient to probiotic-induced changes and possibly resulting in longer lasting probiotic effects compared to adults.
Probiotics are live microorganisms that have been associated with health benefits. However, probiotic effects have not been shown to persist beyond discontinuation of use in adults. The intake of probiotics during the critical window of gut microbiota development in young children, however, may allow for a longer duration of persistence of probiotic bacteria and more stable changes in microbial composition possibly resulting in stable engraftment of the probiotic strains. This study aims is to examine the effect of a 14-day course of a commercially available probiotic yogurt drink on the composition, diversity, and changes in immune biomarkers (e.g. human beta-defensin-2 and calprotectin) of the gut microbiota of healthy children. As well, to assess whether the probiotic strains persists after discontinuation of intake and whether engraftment occurs. By understanding the impact of probiotics on the gut microbiota, we will better understand the mechanism by which probiotics exert their beneficial effects. This may help guide probiotic selection based on the potential short- and long-term effects on the commensal microbiota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Kids Probiotic Yogurt Drink Group | Experimental | Healthy children will be given a commercially available yogurt drink containing a multi-strain probiotic, Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®), daily for 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic yogurt drink | Other | Food product; yogurt drink containing a multi-strain probiotic. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composition and Diversity of Gut Microbiota | Change in microbial community (e.g. alpha and/or beta diversity) post-probiotic | Baseline, 30 days and 90 days |
| Levels of Fecal Biomarkers - beta-defensins-2 (hBD-2) | Change in levels of beta-defensins-2 (hBD-2) | Baseline, 21 days, 30 days, and 90 days |
| Levels of Fecal Biomarkers - Fecal Calprotectin | Change in levels of Fecal Calprotectin | Baseline, 21 days, 30 days, and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Persistence (DOP) | Measure detectable levels of probiotic strains post-treatment | 90 days post intervention |
| Occurrence of Adverse Events | Measure the occurrence and description of adverse events associated with probiotic use |
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Inclusion Criteria:
Participants will be healthy children between 1 to 3 years of age.
Mother of participant is able to communicate in English (read, write, speak), as she will be required to provide her personal and medical history.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 4K1 | Canada |
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All eligible participants will be assigned to receive the commercially available yogurt drink containing a multi-strain probiotic, Bio-Kidz® (12.5 billion CFU/98g; Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2®), daily for 14 days.
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| Through study completion, an average of 121 days. |