The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity

Last updated: February 11, 2021
Sponsor: Medical Universtity of Lodz
Overall Status: Active - Recruiting

Phase

3

Condition

Depression

Metabolic Syndrome

High Cholesterol (Hyperlipidemia)

Treatment

N/A

Clinical Study ID

NCT04756544
RNN/228/20/KE
  • Ages 18-120
  • All Genders

Study Summary

The trial will be a four-arm, parallel group, prospective, randomized, double-blind, controlled design that will include 200 participants and will last 20 weeks. The probiotic preparation will contain Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175. We will assess the level of depression, anxiety and stress, quality of life, blood pressure, body mass index and waist circumference, white blood cells count, serum levels of C-reactive protein, HDL cholesterol, triglicerides, fasting glucose, faecal microbiota composition and the level of some faecal microbiota metabolites, as well as inflammation markers and oxidative stress parameters in serum.

The trial may establish a safe and easy-to-use treatment option as an adjunct in a subpopulation of depressive patients only partially responsive to pharmacologic treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria: Depressive disorders diagnosed according to ICD Age between 18 and 70 years MADRS score >=13 Antidepressant and antianxiety medications or psychotherapy not changed 3 weeks priorto the beginning of the study DMS study groups: MetS diagnosed according to InternationalDiabetes Federation (IDF)

Exclusion

Exclusion Criteria: Pregnancy; An infection and/or treatment with antibiotics in the previous 4 weeks;Supplementation with pro- or prebiotics in the previous 4 weeks; Having a diagnosis ofautoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependentallergy, severe kidney failure or unstable thyroid dysfunction in the previous 4 weeks;Psychiatric comorbidities (except for specific personality disorder, additional specificanxiety disorder and caffeine or nicotine addiction); Regular treatment (more than 3 days aweek) with proton-pump inhibitors (PPIs), metformin, laxatives, systemic steroids ornonsteroidal anti-inflammatory drugs (NSAIDs) in the previous 4 weeks; Following a specificdiet or a significant change in dietary pattern in the previous 4 weeks; Significant changein daily physical activity or an extreme sport activity in the previous 4 weeks;Significant change in dietary supplementation in the previous 4 weeks; Significant changein smoking pattern in the previous 4 weeks; A major neurological disorder or any medicaldisability that may interfere with a subject's ability to complete study procedures; Highrisk of suicide according to Tool of Assessment of Suicide Risk (TASR); Is participatingin, or has recently participated in, another research study involving an intervention whichmay alter outcomes of interest to this study; Any other condition or situation which, inthe view of investigators, would affect the compliance or safety of the individual takingpart; D study groups: MetS diagnosed according to International Diabetes Federation (IDF).

Study Design

Total Participants: 200
Study Start date:
December 17, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Oliwia Gawlik-Kotelnicka

    Łódź, 92216
    Poland

    Active - Recruiting

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