Lactobacillus Helveticus in the Treatment of Major Depression

Double-blind Placebo-controlled Clinical Trial of Lactobacillus Helveticus as an add-on Strategy for the Treatment of Major Depression

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Other: Probiotic; Other: Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Recruiting
      • Hospital das Clinicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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	Other: Maltodextrin; Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the depressive symptoms severity	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in microbiota composition	Microbiota composition will be assessed by Real-Time qPCR.	8 weeks
Changes in the serum levels of biomarkers	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.	8 weeks
Change in perception of stress	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.	8 weeks

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Chair: Aline Silva de Miranda, PhD, Federal University of Minas Gerais; Study Chair: Érica Leandro Marciano Vieira, Federal University of Minas Gerais; Study Chair: Lais Bhering Martins, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: CAAE 83541717.0.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No