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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 (PRO-DEMET)

Primary Purpose

Depressive Disorder, Depression, Anxiety

Status
Recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175
placebo
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 prior to the beginning of the study DMS study groups: MetS diagnosed according to International Diabetes Federation (IDF)

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 of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, severe kidney failure or unstable thyroid dysfunction in the previous 4 weeks; Psychiatric comorbidities (except for specific personality disorder, additional specific anxiety disorder and caffeine or nicotine addiction); Regular treatment (more than 3 days a week) with proton-pump inhibitors (PPIs), metformin, laxatives, systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) in the previous 4 weeks; Following a specific diet or a significant change in dietary pattern in the previous 4 weeks; Significant change in daily physical activity or an extreme sport 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; A major neurological disorder or any medical disability that may interfere with a subject's ability to complete study procedures; High risk of suicide according to Tool of Assessment of Suicide Risk (TASR); Is participating in, or has recently participated in, another research study involving an intervention which 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; D study groups: MetS diagnosed according to International Diabetes Federation (IDF).

Sites / Locations

  • Oliwia Gawlik-KotelnickaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Depressive Disorders + probiotic

Depressive Disorders + placebo

Depressive disorder + metabolic syndrome + probiotic

Depressive disorder + metabolic syndrome + placebo

Arm Description

Outcomes

Primary Outcome Measures

depressive symptoms
MADRS score

Secondary Outcome Measures

Full Information

First Posted
February 11, 2021
Last Updated
February 11, 2021
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT04756544
Brief Title
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
Acronym
PRO-DEMET
Official Title
he Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation and Oxidative Stress Parameters and Faecal Microbiota in Patients With Depression Depending on Metabolic Syndrome Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
December 31, 2022 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression, Anxiety, Stress, Metabolic Syndrome, NAFLD
Keywords
depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depressive Disorders + probiotic
Arm Type
Experimental
Arm Title
Depressive Disorders + placebo
Arm Type
Placebo Comparator
Arm Title
Depressive disorder + metabolic syndrome + probiotic
Arm Type
Experimental
Arm Title
Depressive disorder + metabolic syndrome + placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175
Intervention Description
probiotic
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
depressive symptoms
Description
MADRS score
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 prior to the beginning of the study DMS study groups: MetS diagnosed according to International Diabetes Federation (IDF) 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 of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, severe kidney failure or unstable thyroid dysfunction in the previous 4 weeks; Psychiatric comorbidities (except for specific personality disorder, additional specific anxiety disorder and caffeine or nicotine addiction); Regular treatment (more than 3 days a week) with proton-pump inhibitors (PPIs), metformin, laxatives, systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) in the previous 4 weeks; Following a specific diet or a significant change in dietary pattern in the previous 4 weeks; Significant change in daily physical activity or an extreme sport 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; A major neurological disorder or any medical disability that may interfere with a subject's ability to complete study procedures; High risk of suicide according to Tool of Assessment of Suicide Risk (TASR); Is participating in, or has recently participated in, another research study involving an intervention which 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; D study groups: MetS diagnosed according to International Diabetes Federation (IDF).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliwia Gawlik-kotelnicka
Phone
+48426757236
Email
oliwia.gawlik@umed.lodz.pl
Facility Information:
Facility Name
Oliwia Gawlik-Kotelnicka
City
Łódź
ZIP/Postal Code
92216
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliwia Gawlik-kotelnicka
Phone
+48426757236
Email
oliwia.gawlik@umed.lodz.pl

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33804999
Citation
Gawlik-Kotelnicka O, Skowronska A, Margulska A, Czarnecka-Chrebelska KH, Loniewski I, Skonieczna-Zydecka K, Strzelecki D. The Influence of Probiotic Supplementation on Depressive Symptoms, Inflammation, and Oxidative Stress Parameters and Fecal Microbiota in Patients with Depression Depending on Metabolic Syndrome Comorbidity-PRO-DEMET Randomized Study Protocol. J Clin Med. 2021 Mar 24;10(7):1342. doi: 10.3390/jcm10071342.
Results Reference
derived

Learn more about this trial

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

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