NCT04333277

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2020-04-03
• Last updated: 2021-02-05

Locations

1 site across 1 country: Brazil