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

NCT04756544 | Unknown Phase 3

• 1 other identifier: RNN/228/20/KE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Depression; Anxiety; Stress; Metabolic Syndrome; NAFLD

Keywords

depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress

Outcome Measures

Primary Outcomes (1)

• depressive symptoms

  MADRS score

  2 years

Study Arms (4)

Depressive Disorders + probiotic

EXPERIMENTAL

Dietary Supplement: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175

Depressive Disorders + placebo

PLACEBO COMPARATOR

Other: placebo

Depressive disorder + metabolic syndrome + probiotic

EXPERIMENTAL

Dietary Supplement: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175

Depressive disorder + metabolic syndrome + placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175 DIETARY_SUPPLEMENT

probiotic

Depressive Disorders + probiotic; Depressive disorder + metabolic syndrome + probiotic

placebo OTHER

placebo

Depressive Disorders + placebo; Depressive disorder + metabolic syndrome + placebo

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Oliwia Gawlik-Kotelnicka

Lodz, 92216, Poland

RECRUITING

Related Publications (6)

• Kotelnicka OG, Wysokinski A, Gajewska A, Czarnecka-Chrebelska K, Kopacz K, Skowronska A, Pikus E, Brzezianska-Lasota E, Strzelecki D. Probiotics Decrease C-Reactive Protein Levels in Depression Depending on Metabolic Syndrome Presence or Antidepressant Treatment - Secondary Results of a Randomized Clinical Trial. Curr Neuropharmacol. 2025 Oct 29. doi: 10.2174/011570159X371175251002220658. Online ahead of print.

  PMID: 41177800 DERIVED

• Gawlik-Kotelnicka O, Sobczak M, Palma J, Poplawska M, Skonieczna-Zydecka K, Plewka M, Pawliczak R, Strzelecki D. Does isovaleric acid play a key role in the interaction between probiotics and antidepressants? A secondary analysis of a randomized clinical trial. Comput Struct Biotechnol J. 2025 May 27;27:2275-2287. doi: 10.1016/j.csbj.2025.05.035. eCollection 2025.

  PMID: 40520599 DERIVED

• Gawlik-Kotelnicka O, Rogalski J, Czarnecka-Chrebelska KH, Burzynski J, Jakubowska P, Skowronska A, Strzelecki D. The Interplay Between Depression, Probiotics, Diet, Immunometabolic Health, the Gut, and the Liver-A Secondary Analysis of the Pro-Demet Randomized Clinical Trial. Nutrients. 2024 Nov 24;16(23):4024. doi: 10.3390/nu16234024.

  PMID: 39683419 DERIVED

• Gawlik-Kotelnicka O, Burzynski J, Rogalski J, Skowronska A, Strzelecki D. Probiotics may be useful for drug-induced liver dysfunction in patients with depression - A secondary analysis of a randomized clinical trial. Clin Nutr ESPEN. 2024 Oct;63:604-614. doi: 10.1016/j.clnesp.2024.07.1024. Epub 2024 Jul 30.

  PMID: 39089652 DERIVED

• Gawlik-Kotelnicka O, Margulska A, Pleska K, Skowronska A, Strzelecki D. Metabolic Status Influences Probiotic Efficacy for Depression-PRO-DEMET Randomized Clinical Trial Results. Nutrients. 2024 May 3;16(9):1389. doi: 10.3390/nu16091389.

  PMID: 38732635 DERIVED

• 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.

  PMID: 33804999 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depression; Anxiety Disorders; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Inflammation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oliwia Gawlik-kotelnicka

CONTACT

+48426757236; oliwia.gawlik@umed.lodz.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: December 17, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

PL (1)