Skip to main content
OpenTrials
Completed

NCT Number: NCT02838043

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Depressive Symptoms Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Providence Care - Mental Health Services, Kingston, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Major Depressive Disorder (MDD) by Mini International Neuropsychiatric Interview (MINI)
  • Current depressive episode with a MADRS score of ≥ 20
  • Males and females between ages 18 and 65
  • Able to understand and comply with the requirements of the study
  • Provision of written informed consent

Exclusion criteria

  • Use of any antidepressant drug
  • Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period)
  • Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
  • Milk, yeast, or soy allergy
  • History of alcohol or substance abuse in the past 6 months
  • Daily use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period)
  • Use of any type of laxative
  • Consumption of products fortified in probiotics
  • Severely suicidal
  • Experiencing psychosis or bipolar episode
  • History of epilepsy or uncontrolled seizures

Treatment and study plan

Probio'Stick

Dietary Supplement

A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Primary outcomes

  1. Mood

    Time frame: 8 weeks

    Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.

Secondary outcomes

  1. Anxiety

    Time frame: 8 weeks

    Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).

  2. Cognition

    Time frame: 8 weeks

    Cognition will be assess with the Digit Symbol Substitution Test (DSST).

  3. Sleep

    Time frame: 8 weeks

    Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.

  4. Plasma

    Time frame: 8 weeks

    Plasma will be analyzed to look at levels of inflammatory markers to see whether there is a decrease after 8 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Lallemand Health Solutions
  • McMaster University

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 20, 2016
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.