NCT03430726

ProbGut: Probiotics on the Healthy Gut Microbiota

The ProbGut Study: Effects of Probiotics on the Gut Microbiota of Healthy Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 1 Year – 3 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Probiotic yogurt drink	Food product; yogurt drink containing a multi-strain probiotic.

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-09-30
• Completion: 2018-11-30
• First posted: 2018-02-13
• Last updated: 2018-08-17

Locations

1 site across 1 country: Canada