DepressionPhase 2NCT02469545

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

A Phase 2 study testing Lactobacillus Plantarum 299v, Crystalline cellulose powder and Escitalopram in people with Depression and Anxiety Disorder, run by Medical University of Bialystok at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to determine the influence of supplementation of probiotic Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Depression, Anxiety Disorder
What is being tested?: Lactobacillus Plantarum 299v, Crystalline cellulose powder and Escitalopram
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 sitePoland
Study dates: Jun 2014to Mar 2016
Phase: Phase 2
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Unipolar depression, with at least one depressive episode, present episode since at least 2 weeks, with Hamilton Depression Scale scoring 18 and higher with BMI =18,9 - 29,9 kg/m2

Who cannot join

Inflammatory diseases eg. rheumatoid diseases, inflammatory bowel diseases, autoimmunological diseases
Metabolic diseases e.g. diabetes type I,II, obesity (Body Mass Index)>30 kg/m2
Previously diagnosed other psychiatric diseases other than depression, psychoactive substances abuse, organic brain dysfunctions
Smokers
Patients after surgeries in last 3 months
Oncological patients

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Patients during pregnancy or lactation
Drugs which might influence measured parameters (e.g. lithium, antibiotics, glucocorticosteroids, antipsychotic drugs)
Changes in routine blood biochemical parameters: morphology, electrolytes, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), creatinine, urea, C-reactive protein (CRP), thyroid-stimulating hormone (TSH).

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department of Psychiatry, Medical University of Bialystok
Bialystok

Other trials in Poland

About this study

Read the detailed description

For period of 8 weeks patient will receive probiotic Lactobacillus Plantarum 299V or its placebo as a supplementation of regular depression treatment with SSRI (Escitalopram or Sertraline). Psychometric and biochemical parameters will be monitored and evaluated. At day one, after 3 weeks (day 21) and after 8 weeks (day 56) of the study psychometric parameters will be measured such as Hamilton Depression Rating Scale, PSS-10 Scale, SCL-90 scale. At day one and after 8 weeks (day 56) of the study cognitive functions will be measured using: CVLT- California Verbal Learning Test, RFFT Ruff Figural Fluency Test, Stroop Test, Connecting Points Test (A and B), Attention and Perceptivity Test. At day one and after 8 weeks (day 56) of the study biochemical parameters will be measured such as: morning cortisol, pro and anti-inflammatory cytokines, tryptophan and its kynurenic pathway metabolites concentrations.

Conditions: Depression, Anxiety Disorder
Being tested: Lactobacillus Plantarum 299v, Crystalline cellulose powder, Escitalopram, Sertraline
Keywords: depression, microbiota-gut-brain axis, Lactobacillus Plantarum 299v, probiotic
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.

Lactobacillus Plantarum 299vDrug
Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and probiotic - 2x1 caps. per day of Lactobacillus Plantarum 299V (10mld colony forming units in 1 caps.) for 8 weeks.
Crystalline cellulose powderDrug
Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.
EscitalopramDrug
5-20mg daily
SertralineDrug
50-100mg daily

Study groups in NCT02469545
Study group	Role	What they receive
SSRI and probiotic	Active comparator	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and probiotic (Lactobacillus Plantarum 299v) to a group of patients diagnosed with depression (n=30). Receives: Drug: Lactobacillus Plantarum 299v; Drug: Escitalopram; Drug: Sertraline
SSRI and placebo of probiotic	Placebo comparator	Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and placebo of probiotic (crystalline cellulose powder) to a group of patients diagnosed with depression (n=30). Receives: Drug: Crystalline cellulose powder; Drug: Escitalopram; Drug: Sertraline

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.
Measured: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Evaluation of psychometric parameters - Change in Perceived Stress Scale (PSS-10) from baseline at 3 weeks and 8 weeks of the study.
Measured: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study.
Measured: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study

Secondary outcomes (8)

Cognitive functions evaluation - California Verbal Learning Test (CVLT)
Measured: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)
Measured: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Stroop Test (A and B)
Measured: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Connecting Points Test (A and B)
Measured: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Attention and Perceptivity Test
Measured: At day one, after 8 weeks (day 56) of the study
Biochemical analysis - morning cortisol level
Biochemical analysis will be based on pro-inflammatory and anti-inflammatory cytokines measurements, morning cortisol concentration, tryptophan and its kynurenic pathway metabolites measurements.
Measured: At day one, after 8 weeks (day 56) of the study
Biochemical analysis - cytokines measurements profile
Measured: At day one, after 8 weeks (day 56) of the study
Biochemical analysis - kynurenic pathway metabolites measurements profile
Measured: At day one, after 8 weeks (day 56) of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Mar 2016

First posted11 Jun 2015 (estimated)
Study startJun 2014
Primary completionMar 2016
Study completionMar 2016

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02469545
Sponsor's protocol ID: 133-47818
Status last verified: Aug 2015
First submitted: 29 May 2015
Last updated: 7 Sep 2018
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
ClinicalTrials.gov ID: NCT02469545
Acronym / sponsor ID: 133-47818
Conditions: Depression, Anxiety Disorder
Keywords: depression, microbiota-gut-brain axis, Lactobacillus Plantarum 299v, probiotic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Medical University of BialystokUniversity, hospital or other
Study start: Jun 2014
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 11 Jun 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SSRI and probiotic	Active comparator	Drug: Lactobacillus Plantarum 299v, Drug: Escitalopram, Drug: SertralineAdministering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and probiotic (Lactobacillus Plantarum 299v) to a group of patients diagnosed with depression (n=30).
SSRI and placebo of probiotic	Placebo comparator	Drug: Crystalline cellulose powder, Drug: Escitalopram, Drug: SertralineAdministering antidepressant drug (SSRI - selective serotonin reuptake inhibitor: Escitalopram or Sertraline) and placebo of probiotic (crystalline cellulose powder) to a group of patients diagnosed with depression (n=30).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Unipolar depression, with at least one depressive episode, present episode since at least 2 weeks, with Hamilton Depression Scale scoring 18 and higher with BMI =18,9 - 29,9 kg/m2

Key exclusion criteria (9 listed)

Inflammatory diseases eg. rheumatoid diseases, inflammatory bowel diseases, autoimmunological diseases
Metabolic diseases e.g. diabetes type I,II, obesity (Body Mass Index)>30 kg/m2
Previously diagnosed other psychiatric diseases other than depression, psychoactive substances abuse, organic brain dysfunctions
Smokers
Patients after surgeries in last 3 months

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
Lactobacillus Plantarum 299vAdministering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and probiotic - 2x1 caps. per day of Lactobacillus Plantarum 299V (10mld colony forming units in 1 caps.) for 8 weeks.	Drug	SSRI and probiotic
Crystalline cellulose powderAdministering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.	Drug	SSRI and placebo of probiotic
Escitalopram5-20mg daily	Drug	SSRI and placebo of probiotic, SSRI and probiotic
Sertraline50-100mg daily	Drug	SSRI and placebo of probiotic, SSRI and probiotic

Primary outcome

Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study.
Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Evaluation of psychometric parameters - Change in Perceived Stress Scale (PSS-10) from baseline at 3 weeks and 8 weeks of the study.
Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study
Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study.
Time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study

8 secondary outcomes

Cognitive functions evaluation - California Verbal Learning Test (CVLT)
Time frame: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT)
Time frame: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Stroop Test (A and B)
Time frame: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Connecting Points Test (A and B)
Time frame: At day one, after 8 weeks (day 56) of the study
Cognitive functions evaluation - Attention and Perceptivity Test
Time frame: At day one, after 8 weeks (day 56) of the study
Biochemical analysis - morning cortisol level
Time frame: At day one, after 8 weeks (day 56) of the study
Biochemical analysis - cytokines measurements profile
Time frame: At day one, after 8 weeks (day 56) of the study
Biochemical analysis - kynurenic pathway metabolites measurements profile
Time frame: At day one, after 8 weeks (day 56) of the study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Individual participant dataSharing planned: Undecided

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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.

Leszek Z Rudzki, MD Psychiatry Specialist principal investigator

Department of Psychiatry, Medical University of Bialystok

Napoleon Waszkiewicz, MD PhD study director

Psychiatry Department of Bialystok Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 9 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: finished, as of the sponsor's last update on 7 Sep 2018. 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 Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study. (time frame: At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469545.

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 7 Sep 2018.