search
Back to results

Lactobacillus Helveticus in the Treatment of Major Depression

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic
Maltodextrin
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Hospital das ClínicasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Maltodextrin

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in microbiota composition
Microbiota composition will be assessed by Real-Time qPCR.
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.
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.

Full Information

First Posted
March 25, 2020
Last Updated
February 3, 2021
Sponsor
Federal University of Minas Gerais
search

1. Study Identification

Unique Protocol Identification Number
NCT04333277
Brief Title
Lactobacillus Helveticus in the Treatment of Major Depression
Official Title
Double-blind Placebo-controlled Clinical Trial of Lactobacillus Helveticus as an add-on Strategy for the Treatment of Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm 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.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks
Intervention Type
Other
Intervention Name(s)
Probiotic
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks
Primary Outcome Measure Information:
Title
Change in the depressive symptoms severity
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in microbiota composition
Description
Microbiota composition will be assessed by Real-Time qPCR.
Time Frame
8 weeks
Title
Changes in the serum levels of biomarkers
Description
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.
Time Frame
8 weeks
Title
Change in perception of stress
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio L Teixeira, PhD
Phone
+1 713 486 2555
Email
altexr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Teixeira, PhD
Phone
+1 713 486 2555
Email
altexr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline Silva de Miranda, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Érica Leandro Marciano Vieira
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lais Bhering Martins
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antônio L Teixeira, PhD
Phone
+55 31 3409-8073
Email
altexr@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Lactobacillus Helveticus in the Treatment of Major Depression

We'll reach out to this number within 24 hrs