Lactobacillus Helveticus in the Treatment of Major Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04333277
• Other study ID #: CAAE 83541717.0.0000.5149
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: April 2021

Study information

• Verified date: April 2020
• Source: Federal University of Minas Gerais
• Contact: Antonio L Teixeira, PhD
• Phone: +1 713 486 2555
• Email: altexr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in microbiota composition	Microbiota composition will be assessed by Real-Time qPCR.	8 weeks
Secondary	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
Secondary	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