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.

Study Overview

• Status: Completed
• Conditions: Depression; Depressive Symptoms; Major Depressive Disorder
• Intervention / Treatment: Dietary supplement: Probio'Stick

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3N6
      • Queen's University
    • Kingston, Ontario, Canada, K7L 4X3
      • Providence Care - Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participant; All participants will be experimental and receive Probio'Stick.	Dietary supplement: Probio'Stick; A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood	Mood will be assessed with the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score of 12 indicating remission.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).	8 weeks
Cognition	Cognition will be assess with the Digit Symbol Substitution Test (DSST).	8 weeks
Sleep	Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.	8 weeks
Plasma	Plasma will be analyzed to look at levels of inflammatory markers to see whether there is a decrease after 8 weeks of treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: McMaster University; Lallemand Health Solutions
• Investigators: Principal Investigator: Roumen Milev, PhD, MD, Queen's University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 6016312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared.