Lactobacillus Helveticus in the Treatment of Major Depression

NCT04333277 | Unknown DMC

• 1 other identifier: CAAE 83541717.0.0000.5149
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in microbiota composition

  8 weeks

• Changes in the serum levels of biomarkers

  8 weeks

• Change in perception of stress

  8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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: Probiotic

Maltodextrin

PLACEBO COMPARATOR

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

Other: Maltodextrin

Interventions

Probiotic OTHER

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.

Probiotic

Maltodextrin OTHER

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

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 65 years old;
• Diagnosis of major depression
• Agree to sign the informed consent.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Hospital das Clínicas

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Aline Silva de Miranda, PhD

  Federal University of Minas Gerais

  STUDY CHAIR

• Érica Leandro Marciano Vieira

  Federal University of Minas Gerais

  STUDY CHAIR

• Lais Bhering Martins

  Federal University of Minas Gerais

  STUDY CHAIR

Central Study Contacts

Antonio L Teixeira, PhD

CONTACT

+1 713 486 2555; altexr@gmail.com

Antonio Teixeira, PhD

CONTACT

+1 713 486 2555; altexr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 3, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 5, 2021

Record last verified: 2020-04

Locations

BR (1)