DepressionNCT04753944
Probiotics Therapy of Mood Disorders
A study testing Active Comparator: Probiotic in people with Depression, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Active Comparator: Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2018to 3 Apr 2020
- Phase
- Interventional
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- must presence of mood disorders confirmed by Beck scale (more than 10 points)
- must be able to swallow tablets
Who cannot join
- individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome)
- circulatory disorders patients
- diagnosed coagulopathies,
- diagnosed respiratory disease
- inflammatory bowel disease patients
- addicted to alcohol
- addicted to psychoactive substances,
Trial locations and contacts
1 site in 1 country.
Poland1 site
Pomeranian Medical University
Szczecin, West Pomeranian Voivodeship, 70-393
About this study
Official title: Probiotics Therapy: a New Approach to Therapy of Mood Disorders in Perimenopausal Women
The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
Read the detailed description
The aim: The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
The study hypothesis: By using periodic probiotics therapy it is possible to positively influence the mood of women with depressive syndromes. These efforts focus on the improvement of the functioning of the gut barrier and gut-brain axis. In practice, such activities should lead to the reduction in the dysfunction of the barrier, the reduction of endotoxemia and the concentration of neurotoxic metabolites of tryptophan (in blood) with the simultaneous increase in the content of butyric acid that has a neuroprotective effect.
The of the trial: intervention, cohort, randomized, double-blind, using placebo. A multi-strain probiotic will also be provided ( Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 or maize starch, maltodextrins and vegetable protein/placebo).
The applied method of study:
- a controlled dietary intervention that includes probiotics therapy; the verification of the past nutritional pattern (the Food Frequency Questionnaire); anthropometric measurements;
- psychiatric studies: the evaluation of sleep disorders (the Athens insomnia scale) and mood (the Beck scale), and the worsening of depression (the Hamilton scale);
- biochemical studies: the content of short chain fatty acids (in the stool);
- cytometric studies (B-type lymphocytes' panel, T-type lymphocytes' panel, regulatory T cells' panel);
- genetic (the microbiome of bacteria in the stool, pyrosequencing);
- chromatographic (the derivatives of tryptophan e.g., kynurenine, anthranilic acid, kynureic acid, 3-hydroxykynurenine, 5-hydroxytryptophan, serotonin).
Currently, there is an urgent problem to develop recommendations regarding the nutrition and probiotics therapy that could complement the therapy of women with mood disorders. If the achieved results confirm the study hypothesis, it will be possible to:
- better understand the pathomechanism of mood disorders in the perimenopausal period;
- develop a holistic strategy for depressive disorders in women in the menopause period.
- Conditions
- Depression
- Being tested
- Active Comparator: Probiotic, Placebo group
- Keywords
- probiotics, mood, depressive, therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: ProbioticDietary supplement
Also called Probiotic Ecologic®Barrier (Winclove Probiotics BV)
The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
Placebo groupDietary supplement
Also called Placebo
Patients will be introduced for 5 weeks with placebo consisting of starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily. The treatment will be administered two times a day, during breakfast and supper.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Patients will be introduced for 5 weeks with probiotic therapy (in the study group). They will take Ecologic®Barrier (Winclove Probiotics BV, Amsterdam, The Netherlands), consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58. The probiotic dose is going to be 4 capsules daily (one capsule contains 500 million CFUs of living probiotic strains). The treatment will be administered two times a day, during breakfast and supper. The probiotic formula will be Provided by polish distributor of Winclove products, namely Sanprobi sp. z o. o. sp. k Receives: Dietary Supplement: Active Comparator: Probiotic |
| Placebo group | Placebo comparator | Patients will be introduced for 5 weeks with placebo that consist of maize starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily (one capsule). The treatment will be administered two times a day, during breakfast and supper. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intervention
The verification of the past nutritional pattern (will be asses by Food Freguency Questionnarie). The indicate frequency of food consumption, respondents could choose one of six categories (next converted by researcher into daily frequency): never or very rarely (0 times/day), once a month or less (0.025 times/day), several times a month (0.1 times/day), several times a week (0.571 times/day), daily (1 time/day), or a few times a day (2 times/day)
Measured: 5 weeks
Anthropometric measurements
The verification of body mass during the study will be asses by body mass index (BMI). In order of this, we will measure the height (outcome in cm). BMI will be calculated by dividing body weight (in kilograms) by height squared (in meters).i Finally BMI will be presented in kg/m2.
Measured: 5 weeks
Depression intensity mesurements
Depression intensity will be asses by the Hamilton Rating Scale for Depression (HRSD).Unit HRSD ( 0-7 not depressed, 8-13 mild depression; 14-18 moderate depression (mild); 19-22 moderate depression; > 23 severe depression)
Measured: 5 weeks
The biochemical changes in stool
Observation of biochemical changes short fatty acids (SCFAs) concentration before and after the intervention (SCFA in ng/ml)
Measured: 5 weeks
The cytometric studies
Observation of a change in Mean Fluorescence Intensity (FSC) of lymphocytes B and regulatory T cells before and after intervention in flow cytometry. Assessments by median: midpoint of the population (middle channel)).
Measured: 5 weeks
The stool microbiota changes
Changes in gut microbiota composition and metabolism (16 SrRNA bacterial genomic, bacterial metabolites) at enrollment and at the end-point ( gut microbiota will be asses in Operational taxonomic units (OTUs))
Measured: 5 weeks
Insomnia studies
Assessments using unique measurements Athens insomnia scale ( 0 to < 6 means no insomnia; more than 6 points indicated diagnosis of insomnia)
Measured: 3 months
The Kynureine Pathway
The changes in the tryptophan pathway derivatives before and after intervention will be measured. ( we assess metabolites of kynurenine pathway e.g. 5 HT, HIAA, KYN will be asses by HPLC (in ng/ml)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Dec 2018
- Primary completion1 Jan 2019
- Study completion3 Apr 2020
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention, randomized, double-blind, using placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewa Stachowska, Pomeranian Medical University Szczecin
- Investigators
- Jerzy Samochowiec, prof, MD, Study director, Pomeranian Medical University in Sczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753944
- Sponsor's protocol ID
- Pomeranian Medical Univeristy
- Status last verified
- Feb 2021
- First submitted
- 7 May 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Probiotics Therapy: a New Approach to Therapy of Mood Disorders in Perimenopausal Women
- ClinicalTrials.gov ID
- NCT04753944
- Acronym / sponsor ID
- Pomeranian Medical Univeristy
- Conditions
- Depression
- Keywords
- probiotics, mood, depressive, therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 15 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 evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
Detailed description
The aim: The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
The study hypothesis: By using periodic probiotics therapy it is possible to positively influence the mood of women with depressive syndromes. These efforts focus on the improvement of the functioning of the gut barrier and gut-brain axis. In practice, such activities should lead to the reduction in the dysfunction of the barrier, the reduction of endotoxemia and the concentration of neurotoxic metabolites of tryptophan (in blood) with the simultaneous increase in the content of butyric acid that has a neuroprotective effect.
The of the trial: intervention, cohort, randomized, double-blind, using placebo. A multi-strain probiotic will also be provided ( Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 or maize starch, maltodextrins and vegetable protein/placebo).
The applied method of study:
- a controlled dietary intervention that includes probiotics therapy; the verification of the past nutritional pattern (the Food Frequency Questionnaire); anthropometric measurements;
- psychiatric studies: the evaluation of sleep disorders (the Athens insomnia scale) and mood (the Beck scale), and the worsening of depression (the Hamilton scale);
- biochemical studies: the content of short chain fatty acids (in the stool);
- cytometric studies (B-type lymphocytes' panel, T-type lymphocytes' panel, regulatory T cells' panel);
- genetic (the microbiome of bacteria in the stool, pyrosequencing);
- chromatographic (the derivatives of tryptophan e.g., kynurenine, anthranilic acid, kynureic acid, 3-hydroxykynurenine, 5-hydroxytryptophan, serotonin).
Currently, there is an urgent problem to develop recommendations regarding the nutrition and probiotics therapy that could complement the therapy of women with mood disorders. If the achieved results confirm the study hypothesis, it will be possible to:
- better understand the pathomechanism of mood disorders in the perimenopausal period;
- develop a holistic strategy for depressive disorders in women in the menopause period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention, randomized, double-blind, using placebo.
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: Active Comparator: ProbioticPatients will be introduced for 5 weeks with probiotic therapy (in the study group). They will take Ecologic®Barrier (Winclove Probiotics BV, Amsterdam, The Netherlands), consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58. The probiotic dose is going to be 4 capsules daily (one capsule contains 500 million CFUs of living probiotic strains). The treatment will be administered two times a day, during breakfast and supper. The probiotic formula will be Provided by polish distributor of Winclove products, namely Sanprobi sp. z o. o. sp. k |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupPatients will be introduced for 5 weeks with placebo that consist of maize starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily (one capsule). The treatment will be administered two times a day, during breakfast and supper. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- must presence of mood disorders confirmed by Beck scale (more than 10 points)
- must be able to swallow tablets
Key exclusion criteria (7 listed)
- individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome)
- circulatory disorders patients
- diagnosed coagulopathies,
- diagnosed respiratory disease
- inflammatory bowel disease patients
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 |
|---|---|---|
| Active Comparator: ProbioticAlso: Probiotic Ecologic®Barrier (Winclove Probiotics BV)The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group. | Dietary supplement | Probiotic group |
| Placebo groupAlso: PlaceboPatients will be introduced for 5 weeks with placebo consisting of starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily. The treatment will be administered two times a day, during breakfast and supper. | Dietary supplement | Placebo group |
Primary outcome
Dietary intervention
Time frame: 5 weeks
The verification of the past nutritional pattern (will be asses by Food Freguency Questionnarie). The indicate frequency of food consumption, respondents could choose one of six categories (next converted by researcher into daily frequency): never or very rarely (0 times/day), once a month or less (0.025 times/day), several times a month (0.1 times/day), several times a week (0.571 times/day), daily (1 time/day), or a few times a day (2 times/day)
Anthropometric measurements
Time frame: 5 weeks
The verification of body mass during the study will be asses by body mass index (BMI). In order of this, we will measure the height (outcome in cm). BMI will be calculated by dividing body weight (in kilograms) by height squared (in meters).i Finally BMI will be presented in kg/m2.
Depression intensity mesurements
Time frame: 5 weeks
Depression intensity will be asses by the Hamilton Rating Scale for Depression (HRSD).Unit HRSD ( 0-7 not depressed, 8-13 mild depression; 14-18 moderate depression (mild); 19-22 moderate depression; > 23 severe depression)
The biochemical changes in stool
Time frame: 5 weeks
Observation of biochemical changes short fatty acids (SCFAs) concentration before and after the intervention (SCFA in ng/ml)
The cytometric studies
Time frame: 5 weeks
Observation of a change in Mean Fluorescence Intensity (FSC) of lymphocytes B and regulatory T cells before and after intervention in flow cytometry. Assessments by median: midpoint of the population (middle channel)).
The stool microbiota changes
Time frame: 5 weeks
Changes in gut microbiota composition and metabolism (16 SrRNA bacterial genomic, bacterial metabolites) at enrollment and at the end-point ( gut microbiota will be asses in Operational taxonomic units (OTUs))
Insomnia studies
Time frame: 3 months
Assessments using unique measurements Athens insomnia scale ( 0 to < 6 means no insomnia; more than 6 points indicated diagnosis of insomnia)
The Kynureine Pathway
Time frame: 3 months
The changes in the tryptophan pathway derivatives before and after intervention will be measured. ( we assess metabolites of kynurenine pathway e.g. 5 HT, HIAA, KYN will be asses by HPLC (in ng/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Jerzy Samochowiec, prof, MD study director
Pomeranian Medical University in Sczecin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Probiotic in people with Depression, run by Pomeranian Medical University Szczecin 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 2 inclusion and 7 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: finished, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary intervention (time frame: 5 weeks). The study lists 8 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 16 Feb 2021.