Depressive DisorderPhase 3PRO-DEMETNCT04756544
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
A Phase 3 study testing Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175 in people with Depressive Disorder and Depression, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Depressive Disorder, Depression, Anxiety
- What is being tested?
- Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 17 Dec 2020to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Oliwia Gawlik-Kotelnicka
Lodz, 92216
Oliwia Gawlik-kotelnicka, +48426757236, oliwia.gawlik@umed.lodz.pl
About this study
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
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
- Being tested
- Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175, placebo
- Keywords
- depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress
- Medical subject headings
- Depressive Disorder, Depression, Anxiety Disorders, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175Dietary supplement
probiotic
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Depressive Disorders + probiotic | Experimental | Not described Receives: Dietary Supplement: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175 |
| Depressive Disorders + placebo | Placebo comparator | Not described Receives: Other: placebo |
| Depressive disorder + metabolic syndrome + probiotic | Experimental | Not described Receives: Dietary Supplement: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175 |
| Depressive disorder + metabolic syndrome + placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
MADRS score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start17 Dec 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliwia Gawlik-Kotelnicka, MD, PhD, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756544
- Sponsor's protocol ID
- RNN/228/20/KE
- Acronym
- PRO-DEMET
- Status last verified
- Feb 2021
- First submitted
- 11 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rogalski J, Grzelczyk J, Margulska A, Mirocha G, Budryn G, Strzelecki D, Gawlik-Kotelnicka O. I-FABP, citrulline and non-invasive liver dysfunction indices in patients with depression - cross-sectional study results. BMC Gastroenterol. 2026 Jan 3;26(1):88. doi: 10.1186/s12876-025-04559-7.
PubMed 41484701Kotelnicka 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.
PubMed 41177800Gawlik-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.
PubMed 40520599Gawlik-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.
PubMed 39683419Gawlik-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.
PubMed 39089652Gawlik-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.
PubMed 38732635Gawlik-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.
PubMed 33804999
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04756544
- Acronym / sponsor ID
- PRO-DEMET / RNN/228/20/KE
- Conditions
- Depressive Disorder, Depression, Anxiety, Stress, Metabolic Syndrome, NAFLD
- Keywords
- depression; metabolic syndrome; probiotics; microbiota; inflammation; oxidative stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175probiotic | Dietary supplement | Depressive Disorders + probiotic, Depressive disorder + metabolic syndrome + probiotic |
| placeboplacebo | Other | Depressive Disorders + placebo, Depressive disorder + metabolic syndrome + placebo |
Primary outcome
depressive symptoms
Time frame: 2 years
MADRS score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Derived from this study: PubMed 41484701Rogalski J, Grzelczyk J, Margulska A, Mirocha G, Budryn G, Strzelecki D, Gawlik-Kotelnicka O. I-FABP, citrulline and non-invasive liver dysfunction indices in patients with depression - cross-sectional study results. BMC Gastroenterol. 2026 Jan 3;26(1):88. doi: 10.1186/s12876-025-04559-7.
- Derived from this study: PubMed 41177800Kotelnicka 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.
- Derived from this study: PubMed 40520599Gawlik-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.
- Derived from this study: PubMed 39683419Gawlik-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.
- Derived from this study: PubMed 39089652Gawlik-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.
- Derived from this study: PubMed 38732635Gawlik-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.
- Derived from this study: PubMed 33804999Gawlik-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175 in people with Depressive Disorder and Depression, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliwia Gawlik-kotelnicka (+48426757236, oliwia.gawlik@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depressive symptoms (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756544, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.