NCT04925440

The Effects of Bifidobacterium Longum 1714® in a Population With Low Mood

A Double-blind, Placebo-controlled, Randomised Study to Assess the Effects of Bifidobacterium Longum 1714® in a Population With Low Mood

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: PrecisionBiotics Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Low Mood
• Depressive Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bifidobacterium longum 1714® strain	Probiotic capsules containing 5 x 10\^9 CFUs, corn-starch and magnesium stearate.
DIETARY_SUPPLEMENT	Placebo	Capsules containing corn-starch and magnesium stearate only.

Timeline

• Start date: 2021-09-13
• Primary completion: 2022-08-04
• Completion: 2022-08-19
• First posted: 2021-06-14
• Last updated: 2022-11-10

Locations

1 site across 1 country: Ireland