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TerminatedNCT03277586EPSDUpdated Oct 17, 2024

Effects of Probiotics on Symptoms of Depression

A Phase 3 interventional study of Probio'Stick and Placebo in Depression and Anxiety, sponsored by Dr. Roumen Milev. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Dr. Roumen Milev · Phase 3, Interventional, and Treatment

Why this study was terminated
COVID-19
Phase
Phase 3
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Preclinical and clinical studies have shown that consuming probiotics can improve mood, anxiety, and cognition, as well as alter brain activity in both rodents and healthy humans. Data from our recent open-label, 8-week pilot study provided the first evidence of these effects in depressed patients, with significant improvements observed in overall mood, anhedonia, and sleep quality. To further support this evidence and expand upon the search for biomarkers in depression, data from this pilot study is being used to plan a 16-week, double-blind randomized placebo-controlled trial to assess the effects of probiotics on depression. Participants diagnosed with depression recruited from the greater Kingston area will orally consume a probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum (Probio'Stick, Lallemand Health Solutions) or placebo once daily. Participants will undergo clinical assessments measuring mood, anxiety, cognition, and sleep using a battery of validated clinical scales to assess efficacy of the probiotic alleviating depressive symptoms; sleep will also be assessed objectively with an ambulatory polysomnogram. Neuroimaging data will be collected using magnetic resonance imaging and electroencephalography to look at functional, structural, and electrical changes in the brain associated with consumption of the probiotic. Molecular data will be collected from blood, stool, and urine samples to look at levels of cytokines and serotonin, and explore potential genes and proteins that may predict outcomes in depression. An informatics-based approach will be used to integrate clinical, neuroimaging, and molecular data to look for biomarkers that indicate disease state and predict antidepressant-like response to the probiotic. Results: We expect results to replicate and expand on our pilot data, demonstrating that probiotics are effective in alleviating symptoms of depression, and to find biomarkers that will predict these outcomes. The findings from this study will contribute robust scientific data that is currently lacking in this emerging field.

02

Conditions studied

  • Depression
  • Anxiety
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 as determined by 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

Exclusion Criteria:

  1. Current use of any antidepressant drug
  2. Three or more previous episodes of depression
  3. Failure to respond to another treatment in the current episode
  4. Use of any antibiotic drug in the past 4 weeks (may be eligible to participate after a 1-month washout period). Should a participant require an antibiotic drug during the 16 week study period, they may continue with the study but must take the probiotic 4-6 hours before or after they take the antibiotic.
  5. Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
  6. Milk, yeast, or soy allergy
  7. History of alcohol or substance dependence in the past 6 months
  8. Use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) and during the trial
  9. Use of any type of laxative
  10. Consumption of products fortified in probiotics 2 weeks before and during the trial
  11. High risk of suicide (score 4 or more on item 10 of MADRS)
  12. Psychotic symptoms determined by the MINI
  13. Bipolar Disorder determined by the MINI
  14. Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial (determined by a pregnancy test performed at the screening visit and confirmation of the use of appropriate contraception)
  15. Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
  16. Unstable or severe medical conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
  17. The use of natural health products (NHPs; e.g. St. John's Wort, melatonin, passion flower, etc.) that affect depression or sleep is not allowed in the trial
  18. Electroconvulsive therapy (ECT) in the year prior to participation in the study
  19. Taking medication or other not-permitted treatment that cannot be safely discontinued
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Probio'Stick

    Drug: Probio'Stick

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugProbio'Stick

    Probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum

  • DrugPlacebo

    Identically formulated and packaged inactive substance

05

What researchers measure

Primary outcomes

  1. Mood

    Montgomery-Asberg Depression Rating Scale

    Time frame: 16 weeks

Secondary outcomes

  1. Anxiety

    Generalized Anxiety Disorder 7-item Scale

    Time frame: 16 weeks

  2. Anhedonia

    Snaith Hamilton Pleasure Scale

    Time frame: 16 weeks

  3. Cognition

    CNS Vital Signs

    Time frame: 16 weeks

  4. Cytokines

    Blood plasma

    Time frame: 16 weeks

  5. Serotonin

    Blood Plasma

    Time frame: 16 weeks

  6. Microbiome

    Stool

    Time frame: 16 weeks

  7. Brain structure/function

    fMRI

    Time frame: 8 weeks

06

Study locations

1 site
  • Providence Care Hospital
    Kingston, Ontario K7L 4X3, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03277586
Lead sponsor
Dr. Roumen Milev
Responsible party
Dr. Roumen Milev (Head, Department of Psychiatry, Queen's University) — Sponsor-investigator
First posted
Sep 11, 2017
Start date
May 29, 2018
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update
Oct 17, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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