Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2016

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.

Interventions

  • Drug: Lactobacillus Plantarum 299v
    • Administering antidepressant drug (SSRI – selective serotonin reuptake inhibitor) and probiotic – 2×1 caps. per day of Lactobacillus Plantarum 299V (10mld colony forming units in 1 caps.) for 8 weeks.
  • Drug: Crystalline cellulose powder
    • Administering antidepressant drug (SSRI – selective serotonin reuptake inhibitor) and placebo of probiotic – 2×1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.
  • Drug: Escitalopram
    • 5-20mg daily
  • Drug: Sertraline
    • 50-100mg daily

Arms, Groups and Cohorts

  • Active Comparator: SSRI and probiotic
    • 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).
  • Placebo Comparator: SSRI and placebo of probiotic
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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 will be based on pro-inflammatory and anti-inflammatory cytokines measurements, morning cortisol concentration, tryptophan and its kynurenic pathway metabolites measurements.
  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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 – 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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Bialystok
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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

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