DepressionPhase 3EPSDNCT03277586
Effects of Probiotics on Symptoms of Depression
A Phase 3 study testing Probio'Stick in people with Depression and Anxiety, run by Dr. Roumen Milev at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Probio'Stick
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2018to 30 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 as determined by 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
Who cannot join
- Current use of any antidepressant drug
- Three or more previous episodes of depression
- Failure to respond to another treatment in the current episode
- 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.
- 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
Show all 19Show fewer
- History of alcohol or substance dependence in the past 6 months
- Use of probiotic product in the past 2 weeks (may be eligible to participate after a 2-week washout period) and during the trial
- Use of any type of laxative
- Consumption of products fortified in probiotics 2 weeks before and during the trial
- High risk of suicide (score 4 or more on item 10 of MADRS)
- Psychotic symptoms determined by the MINI
- Bipolar Disorder determined by the MINI
- 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)
- Immunodeficiency (immuno-compromised and immuno-suppressed participants; e.g. AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants)
- Unstable or severe medical conditions (e.g. cancer, cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.)
- 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
- Electroconvulsive therapy (ECT) in the year prior to participation in the study
- Taking medication or other not-permitted treatment that cannot be safely discontinued
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression, Anxiety
- Being tested
- Probio'Stick, Placebo
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probio'StickDrug
Probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum
PlaceboDrug
Identically formulated and packaged inactive substance
| Study group | Role | What they receive |
|---|---|---|
| Probio'Stick | Experimental | Not described Receives: Drug: Probio'Stick |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood
Montgomery-Asberg Depression Rating Scale
Measured: 16 weeks
Secondary outcomes (7)
Anxiety
Generalized Anxiety Disorder 7-item Scale
Measured: 16 weeks
Anhedonia
Snaith Hamilton Pleasure Scale
Measured: 16 weeks
Cognition
CNS Vital Signs
Measured: 16 weeks
Cytokines
Blood plasma
Measured: 16 weeks
Serotonin
Blood Plasma
Measured: 16 weeks
Microbiome
Stool
Measured: 16 weeks
Brain structure/function
fMRI
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start29 May 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 16-week Double-blind randomized placebo-controlled dual-phase trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Roumen Milev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Roumen Milev, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277586
- Sponsor's protocol ID
- 6020656
- Acronym
- EPSD
- Status last verified
- Jan 2021
- First submitted
- 1 Sep 2017
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotics on Symptoms of Depression
- ClinicalTrials.gov ID
- NCT03277586
- Acronym / sponsor ID
- EPSD / 6020656
- Conditions
- Depression, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dr. Roumen MilevUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 16-week Double-blind randomized placebo-controlled dual-phase trial
| Arm | Type | Receives |
|---|---|---|
| Probio'Stick | Experimental | Drug: Probio'Stick |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 as determined by 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
Key exclusion criteria (19 listed)
- Current use of any antidepressant drug
- Three or more previous episodes of depression
- Failure to respond to another treatment in the current episode
- 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.
- Use of any sleep medication in the past 4 weeks (may be eligible to participate after a 1-month washout period)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probio'StickProbiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum | Drug | Probio'Stick |
| PlaceboIdentically formulated and packaged inactive substance | Drug | Placebo |
Primary outcome
Mood
Time frame: 16 weeks
Montgomery-Asberg Depression Rating Scale
7 secondary outcomes
Anxiety
Time frame: 16 weeks
Anhedonia
Time frame: 16 weeks
Cognition
Time frame: 16 weeks
Cytokines
Time frame: 16 weeks
Serotonin
Time frame: 16 weeks
Microbiome
Time frame: 16 weeks
Brain structure/function
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probio'Stick in people with Depression and Anxiety, run by Dr. Roumen Milev at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.