At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tolerability and Risk of Adverse Events With a Probiotic Supplement: A Randomised and Placebo Controlled Study in Healthy Individuals
In Brief
A clinical study evaluating Placebo, High dose F. prausnitzii and D. piger, and 1 other intervention for Healthy Individuals. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The butyrate-producing bacterium Faecalibacterium prausnitzii is abundant in the human bowel and can make up to 5% of the gastrointestinal flora in healthy individuals. A reduced presence of it has been associated with an imbalance in the gastrointestinal flora of metabolic syndromes such as type 2 diabetes, fat liver, and in inflammatory bowel disease. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with F.prausnitzii (combined with D. piger) once a day for 8 consecutive weeks is tolerated compared to placebo and if it can affect the metabolism in a positive way.
Study Details
Timeline
Interventions
Dietary supplementation with placebo once a day for 8 consecutive weeks
Dietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks
Dietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks