Lactobacillus Helveticus in the Treatment of Major Depression

Not Applicable

• Conditions: Depression
• Interventions: Other: Maltodextrin; Other: Probiotic

• Registration Number: NCT04333277
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-03-25
• Status Verified: 2020-04
• Study Start: 2020-04-01
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-05
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks
Probiotic	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.

Primary Outcome Measures

Name	Time	Method
Change in the depressive symptoms severity	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital das Clínicas; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil