The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms, as Well as the Function and Composition of Gut Microbiota, Metabolic, Inflammation, and Oxidative Stress Markers in Patients With Depression

January 29, 2023 updated by: Dominik Strzelecki, Medical University of Lodz

The aim of this study is to gather empirical evidence which will enable to evaluate the impact of probiotic supplementation on the severity of anxiety and depressive symptoms, function, and composition of gut microbiota, metabolic parameters, inflammation, and oxidative stress markers in patients with diagnosed depressive disorders.

The designed study will be prospective, randomized, placebo-controlled, and double-blind. The intervention period will last 8 weeks for each patient. The study will be conducted on 100 patients in total, who will be randomly divided into two groups, consisting of 50 patients each.

Patients included in Group I (PRO-D) will receive one capsule daily containing a probiotic mixture at a daily dose of 3×109 colony-forming units (CFU). The probiotic will be composed of two bacteria strains: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175, and excipients: potato starch, magnesium stearate, and the capsule shell, made of hydroxypropylmethylcellulose.

Patients included in Group II (PLC-D) will receive daily the same capsule, containing only excipients: potato starch, maltodextrin, and the capsule shell. The color, smell, and taste of the placebo will not be different from those included in the probiotic capsule.

Patients will be considered compliant if they consume >= 80% of the supplements.

The primary outcome measures will be the severity of depressive anxiety and stress symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) and the Depression, Anxiety, Stress Scale (DASS) with subscales scores, the quality of life level assessed with the WHOQOL-BREF instrument. The secondary outcomes measures will include: blood pressure (BP), body mass index (BMI) and waist circumference (WC) measures, fasting glucose (fGlc), HDL cholesterol (HDL-C), triglycerides (TG), white blood cells count (WBC), neutrofiles, serum levels of C-reactive protein (CRP), the level of faecal SCFAs, faecal microbiota α-diversity and the level of oxidative stress parameters (total antioxidant capacity (TAC) and malondialdehyde (MDA)) in the blood serum.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Łódź, Poland, 92-216
        • Recruiting
        • Central Teaching Hospital, Medical University of Lodz
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anna Skowrońska, MD
        • Sub-Investigator:
          • Oliwia Gawlik-Kotelnicka
        • Principal Investigator:
          • Dominik Strzelecki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Depressive disorders diagnosed according to ICD-11,
  2. Age between 18 - 70 years,
  3. MADRS score >=13,
  4. Antidepressant and antianxiety medications not changed 3 weeks prior to the recruitment visit.

Exclusion Criteria:

  1. Pregnancy,
  2. An infection/vaccination and/or treatment with antibiotics in the previous 4 weeks,
  3. Supplementation with pro- or prebiotics in the previous 4 weeks,
  4. Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, or severe kidney failure in the previous 4 weeks,
  5. body mass index (BMI)> 35,
  6. glomerular filtration rate (GFR)< 30 ml/min/1,72 m2,
  7. unstable thyroid dysfunction (TSH < 0,27 or > 4,2 μIU/ml) in the previous 4 weeks,
  8. Psychiatric comorbidities (except specific personality disorder, additional specific anxiety disorder, and caffeine, and nicotine addiction),
  9. Regular treatment (more than 3 days a week) with PPIs, metformin, laxatives, systemic steroids, or NSAIDs in the previous 4 weeks,
  10. Significant change in dietary pattern in the previous 4 weeks,
  11. Significant change in daily physical activity or extreme sports activity in the previous 4 weeks,
  12. Significant change in dietary supplementation in the previous 4 weeks,
  13. Significant change in smoking pattern in the previous 4 weeks,
  14. High risk of suicide,
  15. Is participating in, or has recently participated in, another research study involving an intervention that may alter outcomes of interest to this study,
  16. Any other condition or situation which, in the view of investigators, would affect the compliance or safety of the individual taking part.

Reasons for the participant to be discontinued from the study:

  1. Withdrawal of informed consent,
  2. An infection/vaccination and/or treatment with antibiotics during the trial,
  3. Consuming any other than studied probiotics during the trial,
  4. Lack of compliance with the probiotic supplementation,
  5. Any change in the drug regimen during the study,
  6. Exclusion criteria found after enrolment,
  7. Any serious adverse event during the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group I "PRO-D"
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
Dietary supplement: Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
We plan to investigate the impact of the Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell on clinical and biochemical parameters in the experimental group.
PLACEBO_COMPARATOR: Group II "PLC-D"
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo.
Other: control group
We plan to investigate the impact of a placebo on clinical and biochemical parameters in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 8 weeks
10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disturbances. The overall score ranges from 0 to 60 (most severe depression).
8 weeks
Depression, Anxiety, Stress Scale (DASS21)
Time Frame: 8 weeks
21-item self-administered questionnaire, designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. These scores ranged from 0 ("did not apply to me at all") to 3 ("apply to me very much or most of the time").
8 weeks
The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
Time Frame: 8 weeks
6-item questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment validated for several countries.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure (BP)
Time Frame: 8 weeks
Routine measurements in a seated position after 5 minutes of rest.
8 weeks
Body mass index (BMI)
Time Frame: 8 weeks
Defined as the body mass (kg) divided by the square of the body height (m). Major adult BMI classifications are underweight (under 18.5 kg/m2), normal weight (18.5 to 24.9), overweight (25 to 29.9), and obese (30 or more).
8 weeks
Waist circumference (WC)
Time Frame: 8 weeks
Wrapping the tape measure around the widest part of stomach, across the navel.
8 weeks
White blood cells count (WBC)
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
Neutrofiles count
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
Serum levels of C-reactive protein (CRP)
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
The level of faecal short-chain fatty acids (SCFAs)
Time Frame: 8 weeks
Each patient included in the study will be asked to collect a sample of feces twice in a specially designed double sealed bag, which will allow keeping anaerobic conditions.
8 weeks
Faecal microbiota α-diversity
Time Frame: 8 weeks
Each patient included in the study will be asked to collect a sample of feces twice in a specially designed double sealed bag, which will allow keeping anaerobic conditions.
8 weeks
Total antioxidant capacity (TAC) in the blood serum
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
Malondialdehyde (MDA) level in the blood serum
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
Fasting glucose (fGlc)
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
HDL cholesterol (HDL-C)
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks
Triglycerides (TG)
Time Frame: 8 weeks
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Principal Investigator: Dominik Strzelecki, MD, PhD, Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2021

Primary Completion (ANTICIPATED)

May 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULodzAff_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will publish the study protocol and results with IPD

IPD Sharing Time Frame

After the publication of both, the study protocol and results.

IPD Sharing Access Criteria

open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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