Lactobacillus Helveticus in the Treatment of Major Depression

Federal University of Minas Gerais

Status: Unknown

Conditions: Depression

Treatments: Other: Probiotic; Other: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT04333277

CAAE 83541717.0.0000.5149

Details and patient eligibility

About

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 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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.

Treatment:

Other: Probiotic

Maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Other: Maltodextrin