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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02838043
Recruitment Status : Active, not recruiting
First Posted : July 20, 2016
Last Update Posted : December 24, 2018
Sponsor:
Collaborators:
Lallemand Health Solutions
McMaster University
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Depression Depressive Symptoms Dietary Supplement: Probio'Stick Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy, Safety, and Tolerability of Probiotics on the Mood and Cognition of Depressed Patients
Study Start Date : August 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838043


Locations
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Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L 3N6
Providence Care - Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
Lallemand Health Solutions
McMaster University
Investigators
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Principal Investigator: Roumen Milev, PhD, MD Queen's University

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Responsible Party: Dr. Roumen Milev, Psychiatrist, Queen's University
ClinicalTrials.gov Identifier: NCT02838043     History of Changes
Other Study ID Numbers: 6016312
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared.

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms