NCT02838043

The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will be an 8-week open-label pilot study examining subjective and objective changes in mood, anxiety, cognition, and sleep before and after the introduction of a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum in 10 treatment-naïve participants diagnosed with major depressive disorder (MDD). In order to examine the full composition of the micro biome, the investigators will also be collecting and analyzing fecal samples as well as blood samples to examine changes in plasma levels of inflammatory markers, 5-HT, and tryptophan in order to look at possible underlying mechanisms of any changes seen.

Conditions

• Major Depressive Disorder
• Depression
• Depressive Symptoms

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probio'Stick	A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2016-07-20
• Last updated: 2019-06-14

Locations

2 sites across 1 country: Canada