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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838043
• Other study ID #: 6016312
• Status: Completed
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: May 2018

Study information

• Verified date: June 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms
• Major Depressive Disorder

Intervention

Dietary Supplement:
• Probio'Stick
A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum

Locations

Country	Name	City	State
Canada	Providence Care - Mental Health Services	Kingston	Ontario
Canada	Queen's University	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	Lallemand Health Solutions, McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Anxiety	Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7).	8 weeks
Secondary	Cognition	Cognition will be assess with the Digit Symbol Substitution Test (DSST).	8 weeks
Secondary	Sleep	Sleep will be assessed objectively using a polysomnogram to look at changes electrophysiological sleep architecture after 8 weeks of treatment.	8 weeks
Secondary	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