Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment
NCT02469545, Phase 2, Completed, Medical University of Bialystok
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment | ClinicalTrials.gov |
| NCT number | NCT02469545 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Medical University of Bialystok | ClinicalTrials.gov |
| Conditions | Depression, Anxiety Disorder | ClinicalTrials.gov |
| Interventions | Lactobacillus Plantarum 299v, Crystalline cellulose powder, Escitalopram, Sertraline | ClinicalTrials.gov |
| First posted | 2015-06-11 | ClinicalTrials.gov |
| Last updated | 2018-09-07 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evaluation of psychometric parameters - Change in Hamilton Depression Rating Scale from baseline at 3 weeks and 8 weeks of the study. | At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Primary | Evaluation of psychometric parameters - Change in Perceived Stress Scale (PSS-10) from baseline at 3 weeks and 8 weeks of the study. | At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Primary | Evaluation of psychometric parameters - Change in Symptom Checklist 90 Scale (SCL-90) from baseline at 3 weeks and 8 weeks of the study. | At day one, after 3 weeks (day 21), after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Cognitive functions evaluation - California Verbal Learning Test (CVLT) | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Cognitive functions evaluation - Ruff Figural Fluency Test (RFFT) | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Cognitive functions evaluation - Stroop Test (A and B) | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Cognitive functions evaluation - Connecting Points Test (A and B) | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Cognitive functions evaluation - Attention and Perceptivity Test | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Biochemical analysis - morning cortisol level | At day one, after 8 weeks (day 56) of the study | Biochemical analysis will be based on pro-inflammatory and anti-inflammatory cytokines measurements, morning cortisol concentration, tryptophan and its kynurenic pathway metabolites measurements. | ClinicalTrials.gov |
| Secondary | Biochemical analysis - cytokines measurements profile | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov | |
| Secondary | Biochemical analysis - kynurenic pathway metabolites measurements profile | At day one, after 8 weeks (day 56) of the study | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Design Fluency Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)