At a glance
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A 12-week Randomized, Double-Blind Controlled Trial to Evaluate the Tolerability and Gastrointestinal Response of a Novel, Multi-Strain Synbiotic (PDS-08™) in Children Ages 3-17
In Brief
A clinical study evaluating PDS-08 and Placebo for Constipation and 3 related conditions. Completed, enrolled 64 participants across 1 site.
Detailed Summary
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored. The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.
Study Details
Timeline
Interventions
PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic.
Placebo sachets will contain potato or tapioca maltodextrin.