Depressive Symptoms Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomised Study to Assess the Effects of Bifidobacterium Longum 1714® in a Population With Low Mood
A randomised, double-blind, placebo-controlled clinical trial to evaluate the effect of 8 weeks of supplementation with Bifidobacterium longum 1714® strain on Beck's Depression Inventory-II Score in adults who experience low mood.
This is a randomized, double-blind, placebo-controlled, parallel group study, designed to assess the effectiveness & safety of Bifidobacterium longum 1714® strain in people with low mood. The 8-week intervention study will be conducted in 168 adults, aged ≥18 to ≤70 years, who experience low mood, and experience mild or moderate depression, according to the Beck's Depression Inventory II (Total score 14-28). The study will consist of 4 visits over a 10 week period commencing with a screening visit. The second visit will be the baseline (start of intervention - either active or placebo), followed by third (mid-intervention), fourth (end of treatment). Questionnaires will be administered from the first to the fifth visit and safety and research bloods will be collected at each visit throughout the trial. ;
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