Lactobacillus Helveticus in the Treatment of Major Depression

Overview

The main objective of the study is to evaluate whether the association of the probiotic Lactobacillus helveticus to standard antidepressant will contribute to the treatment of major depression.

Full Title of Study: “Double-blind Placebo-controlled Clinical Trial of Lactobacillus Helveticus as an add-on Strategy for the Treatment of Major Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2021

Detailed Description

Patients with the diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria will receive one daily oral dose of 1 × 10^9 colony-forming units (CFUs) of Lactobacillus helveticus or placebo for 8 weeks in addition to conventional antidepressant treatment.

Interventions

  • Other: Probiotic
    • Patients with major depression (both sexes) will receive capsules with 1 × 10^9 CFUs of Lactobacillus helveticus in addition to a conventional antidepressant treatment for 8 weeks.
  • Other: Maltodextrin
    • Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks

Arms, Groups and Cohorts

  • Experimental: Probiotic
    • Patients with major depression (both sexes) will receive capsules with 1 × 10^9 CFUs of Lactobacillus helveticus in addition to a conventional antidepressant treatment for 8 weeks.
  • Placebo Comparator: Maltodextrin
    • Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Change in the depressive symptoms severity
    • Time Frame: 8 weeks
    • Depression symptoms severity will be assessed through the Montgomery-Asberg Depression Rating Scale (MADRS) (Minimum: 0 to 6 – normal/symptom absent/ Maximum: >34 – severe depression). Higher scores mean a worse outcome.

Secondary Measures

  • Change in microbiota composition
    • Time Frame: 8 weeks
    • Microbiota composition will be assessed by Real-Time qPCR.
  • Changes in the serum levels of biomarkers
    • Time Frame: 8 weeks
    • Inflammatory markers (adiponectin, resistin, leptin, TNF, IL6 and IL10) and neurotrophic factors (GDNF, NGF) will be assessed by enzyme-linked immunosorbent assay (ELISA). Markers will be measured in pg/ml.
  • Change in perception of stress
    • Time Frame: 8 weeks
    • Perception of stress will be assessed by Perceived Stress Scale (PSS). It is a measure of the degree to which life situations are assessed as stressful. Range from 0 to 40 with higher scores indicating worse outcome.

Participating in This Clinical Trial

Inclusion Criteria

  • Aged between 18 and 65 years old; – Diagnosis of major depression – Agree to sign the informed consent. Exclusion Criteria:

  • Treatment with anti-inflammatory drugs or antibiotics of any pharmacological classes in the month before treatment enrollment; – Use of dietary supplementation (herbal supplements, other pro- or prebiotics).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Principal Investigator: Antonio L Teixeira Jr, Principal Investigator – Federal University of Minas Gerais
  • Overall Official(s)
    • Aline Silva de Miranda, PhD, Study Chair, Federal University of Minas Gerais
    • Érica Leandro Marciano Vieira, Study Chair, Federal University of Minas Gerais
    • Lais Bhering Martins, Study Chair, Federal University of Minas Gerais
  • Overall Contact(s)
    • Antonio L Teixeira, PhD, +1 713 486 2555, altexr@gmail.com

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