DepressionPhase 2NCT05717946
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
A Phase 2 study testing Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell. in people with Depression and Anxiety, run by Medical University of Lodz at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jan 2021to 31 Dec 2023
- Phase
- Phase 2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Central Teaching Hospital, Medical University of Lodz
Lodz, 92-216
Dominik Strzelecki, MD, PhD, +48426757371, dominik.strzelecki@umed.lodz.pl
Anna Skowrońska, MD, +48426757371, anna.zabka@gmail.com
About this study
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.
Read more
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.
- Conditions
- Depression, Anxiety
- Being tested
- Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell., control group
- Keywords
- probiotics, depression, anxiety, microbiome, metabolism
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.Dietary supplement
We plan to investigate the impact of the Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell on clinical and biochemical parameters in the experimental group.
control groupOther
We plan to investigate the impact of a placebo on clinical and biochemical parameters in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Group I "PRO-D" | Experimental | 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. Receives: Dietary Supplement: Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell. |
| Group II "PLC-D" | Placebo comparator | 50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
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").
Measured: 8 weeks
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.
Measured: 8 weeks
Secondary outcomes (13)
Blood pressure (BP)
Routine measurements in a seated position after 5 minutes of rest.
Measured: 8 weeks
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).
Measured: 8 weeks
Waist circumference (WC)
Wrapping the tape measure around the widest part of stomach, across the navel.
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start4 Jan 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, placebo-controlled, and double-blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik Strzelecki, Medical University of Lodz
- Investigators
- Dominik Strzelecki, MD, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717946
- Sponsor's protocol ID
- MULodzAff_1
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will publish the study protocol and results with IPD
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05717946
- Acronym / sponsor ID
- MULodzAff_1
- Conditions
- Depression, Anxiety
- Keywords
- probiotics, depression, anxiety, microbiome, metabolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Feb 2023 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, placebo-controlled, and double-blind trial
| Arm | Type | Receives |
|---|---|---|
| Group I "PRO-D" | Experimental | Dietary Supplement: 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 probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell. |
| Group II "PLC-D" | Placebo comparator | Other: control group50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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,
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 |
|---|---|---|
| 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. | Dietary supplement | Group I "PRO-D" |
| control groupWe plan to investigate the impact of a placebo on clinical and biochemical parameters in the control group. | Other | Group II "PLC-D" |
Primary outcome
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).
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").
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.
13 secondary outcomes
Blood pressure (BP)
Time frame: 8 weeks
Body mass index (BMI)
Time frame: 8 weeks
Waist circumference (WC)
Time frame: 8 weeks
White blood cells count (WBC)
Time frame: 8 weeks
Neutrofiles count
Time frame: 8 weeks
Serum levels of C-reactive protein (CRP)
Time frame: 8 weeks
The level of faecal short-chain fatty acids (SCFAs)
Time frame: 8 weeks
Faecal microbiota α-diversity
Time frame: 8 weeks
Total antioxidant capacity (TAC) in the blood serum
Time frame: 8 weeks
Malondialdehyde (MDA) level in the blood serum
Time frame: 8 weeks
Fasting glucose (fGlc)
Time frame: 8 weeks
HDL cholesterol (HDL-C)
Time frame: 8 weeks
Triglycerides (TG)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes. We will publish the study protocol and results with IPD
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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.
Dominik Strzelecki, MD, PhD principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell. in people with Depression and Anxiety, 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 4 inclusion and 24 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 8 Feb 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dominik Strzelecki, MD, PhD (+48426757371, dominik.strzelecki@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.