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

NCT02838043 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-06-14

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Probio'Stick

A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Sponsors & Collaborators

  • Lallemand Health Solutions

    collaborator INDUSTRY

  • McMaster University

    collaborator OTHER

  • Queen's University

    lead OTHER

Principal Investigators

  • Roumen Milev, PhD, MD · Queen's University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02838043 on ClinicalTrials.gov