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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04333277

Enrollment

Registered

2020-04-03

Start date

2020-04-01

Completion date

2021-04-30

Last updated

2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

OTHERProbiotic

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.

OTHERMaltodextrin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Brazil

Contacts

Primary ContactAntonio L Teixeira, PhD

altexr@gmail.com+1 713 486 2555

Backup ContactAntonio Teixeira, PhD