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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

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
control group
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring probiotics, depression, anxiety, microbiome, metabolism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Depressive disorders diagnosed according to ICD-11, Age between 18 - 70 years, MADRS score >=13, Antidepressant and antianxiety medications not changed 3 weeks prior to the recruitment visit. Exclusion Criteria: Pregnancy, An infection/vaccination and/or treatment with antibiotics in the previous 4 weeks, Supplementation with pro- or prebiotics in the previous 4 weeks, Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, or severe kidney failure in the previous 4 weeks, body mass index (BMI)> 35, glomerular filtration rate (GFR)< 30 ml/min/1,72 m2, unstable thyroid dysfunction (TSH < 0,27 or > 4,2 μIU/ml) in the previous 4 weeks, Psychiatric comorbidities (except specific personality disorder, additional specific anxiety disorder, and caffeine, and nicotine addiction), Regular treatment (more than 3 days a week) with PPIs, metformin, laxatives, systemic steroids, or NSAIDs in the previous 4 weeks, Significant change in dietary pattern in the previous 4 weeks, Significant change in daily physical activity or extreme sports activity in the previous 4 weeks, Significant change in dietary supplementation in the previous 4 weeks, Significant change in smoking pattern in the previous 4 weeks, High risk of suicide, Is participating in, or has recently participated in, another research study involving an intervention that may alter outcomes of interest to this study, 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: Withdrawal of informed consent, An infection/vaccination and/or treatment with antibiotics during the trial, Consuming any other than studied probiotics during the trial, Lack of compliance with the probiotic supplementation, Any change in the drug regimen during the study, Exclusion criteria found after enrolment, Any serious adverse event during the trial.

Sites / Locations

  • Central Teaching Hospital, Medical University of LodzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group I "PRO-D"

Group II "PLC-D"

Arm Description

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.

50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo.

Outcomes

Primary Outcome Measures

Montgomery-Åsberg Depression Rating Scale (MADRS)
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).
Depression, Anxiety, Stress Scale (DASS21)
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").
The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
6-item questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment validated for several countries.

Secondary Outcome Measures

Blood pressure (BP)
Routine measurements in a seated position after 5 minutes of rest.
Body mass index (BMI)
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).
Waist circumference (WC)
Wrapping the tape measure around the widest part of stomach, across the navel.
White blood cells count (WBC)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Neutrofiles count
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Serum levels of C-reactive protein (CRP)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
The level of faecal short-chain fatty acids (SCFAs)
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.
Faecal microbiota α-diversity
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.
Total antioxidant capacity (TAC) in the blood serum
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Malondialdehyde (MDA) level in the blood serum
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Fasting glucose (fGlc)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
HDL cholesterol (HDL-C)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Triglycerides (TG)
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m

Full Information

First Posted
January 6, 2023
Last Updated
January 29, 2023
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT05717946
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lodz

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
probiotics, depression, anxiety, microbiome, metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, placebo-controlled, and double-blind trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind trial, independent researcher is responsible for randomization and blinding.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I "PRO-D"
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II "PLC-D"
Arm Type
Placebo Comparator
Arm Description
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
Intervention Description
We plan to investigate the impact of the Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell on clinical and biochemical parameters in the experimental group.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
We plan to investigate the impact of a placebo on clinical and biochemical parameters in the control group.
Primary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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).
Time Frame
8 weeks
Title
Depression, Anxiety, Stress Scale (DASS21)
Description
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").
Time Frame
8 weeks
Title
The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
Description
6-item questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment validated for several countries.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Blood pressure (BP)
Description
Routine measurements in a seated position after 5 minutes of rest.
Time Frame
8 weeks
Title
Body mass index (BMI)
Description
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).
Time Frame
8 weeks
Title
Waist circumference (WC)
Description
Wrapping the tape measure around the widest part of stomach, across the navel.
Time Frame
8 weeks
Title
White blood cells count (WBC)
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
Neutrofiles count
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
Serum levels of C-reactive protein (CRP)
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
The level of faecal short-chain fatty acids (SCFAs)
Description
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.
Time Frame
8 weeks
Title
Faecal microbiota α-diversity
Description
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.
Time Frame
8 weeks
Title
Total antioxidant capacity (TAC) in the blood serum
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
Malondialdehyde (MDA) level in the blood serum
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
Fasting glucose (fGlc)
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
HDL cholesterol (HDL-C)
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks
Title
Triglycerides (TG)
Description
The collection will be performed under conditions of fasting, upon overnight resting, in the morning, between 8:00 and 10:00 a.m
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Depressive disorders diagnosed according to ICD-11, Age between 18 - 70 years, MADRS score >=13, Antidepressant and antianxiety medications not changed 3 weeks prior to the recruitment visit. Exclusion Criteria: Pregnancy, An infection/vaccination and/or treatment with antibiotics in the previous 4 weeks, Supplementation with pro- or prebiotics in the previous 4 weeks, Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, or severe kidney failure in the previous 4 weeks, body mass index (BMI)> 35, glomerular filtration rate (GFR)< 30 ml/min/1,72 m2, unstable thyroid dysfunction (TSH < 0,27 or > 4,2 μIU/ml) in the previous 4 weeks, Psychiatric comorbidities (except specific personality disorder, additional specific anxiety disorder, and caffeine, and nicotine addiction), Regular treatment (more than 3 days a week) with PPIs, metformin, laxatives, systemic steroids, or NSAIDs in the previous 4 weeks, Significant change in dietary pattern in the previous 4 weeks, Significant change in daily physical activity or extreme sports activity in the previous 4 weeks, Significant change in dietary supplementation in the previous 4 weeks, Significant change in smoking pattern in the previous 4 weeks, High risk of suicide, Is participating in, or has recently participated in, another research study involving an intervention that may alter outcomes of interest to this study, 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: Withdrawal of informed consent, An infection/vaccination and/or treatment with antibiotics during the trial, Consuming any other than studied probiotics during the trial, Lack of compliance with the probiotic supplementation, Any change in the drug regimen during the study, Exclusion criteria found after enrolment, Any serious adverse event during the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Strzelecki, MD, PhD
Phone
+48426757371
Email
dominik.strzelecki@umed.lodz.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Skowrońska, MD
Phone
+48426757371
Email
anna.zabka@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Strzelecki, MD, PhD
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Teaching Hospital, Medical University of Lodz
City
Łódź
ZIP/Postal Code
92-216
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Strzelecki, MD, PhD
Phone
+48426757371
Email
dominik.strzelecki@umed.lodz.pl
First Name & Middle Initial & Last Name & Degree
Anna Skowrońska, MD
Phone
+48426757371
Email
anna.zabka@gmail.com
First Name & Middle Initial & Last Name & Degree
Anna Skowrońska, MD
First Name & Middle Initial & Last Name & Degree
Oliwia Gawlik-Kotelnicka
First Name & Middle Initial & Last Name & Degree
Dominik Strzelecki

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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