Psoriatic ArthritisMEDIPSANCT04588623
The MEDIPSA Clinical Trial
A study testing Omnibiotic Stress Repair (OBSR) in people with Psoriatic Arthritis, run by Medical University of Graz at 1 site in Austria.
Trial summary
The main purpose of this study is to validate the positive effect of "Omnibiotic Stress Repair" on patients with active psoriatic Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Omnibiotic Stress Repair (OBSR)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteAustria
- Study dates
- 25 Nov 2020to 14 Mar 2023
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient ≥18 years and <90 years of age
- PsA according to CASPAR criteria
- MoDA defined by a PASDAS >3.2 - <5.4
- Stable immunomodulatory therapy for the last 12 weeks before baseline (no change in bDMARD/sDMARD/glucocorticoid treatment)
- Written informed consent
Who cannot join
- History of bariatric surgery
- Prior use of probiotics in the last 24 weeks
- Use of probiotics, other than the study product, during the study period.
- Antibiotic therapy within the last 4 weeks before inclusion
- Inflammatory bowel disease
- Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure
Show all 10Show fewer
- Recent (less than 12 weeks) stroke
- Known malignancy
- Inability of the patient to follow the treatment protocol
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Probiotic Modulation of Enteral Dysbiosis on dIsease Activity in Patients With PSoriatic Arthritis
The main purpose of this study is to validate the positive effect of "Omnibiotic Stress Repair" on patients with active psoriatic Arthritis.
Read the detailed description
This is a single center, double blind (patients and investigators), Placebo controlled randomized trial.
Consecutive patients with Psoriatic Arthritis (PsA) in moderate disease activity (Psoriatic Arthritis Disease Activity Score: PASDAS >3.2 - <5.4) on a stable treatment (no immunomodulatory treatment change in the last 3 months) with biological (bDMARDs) and/or synthetic disease modifying anti-rheumatic drugs (sDMARDs) and/or glucocorticoids will be included in the study. Clinical assessment will be scheduled at baseline, 12 weeks and 24 weeks.
- Conditions
- Psoriatic Arthritis
- Being tested
- Omnibiotic Stress Repair (OBSR), Placebo
- Keywords
- psoriatic arthritis, probiotics, microbiome
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnibiotic Stress Repair (OBSR)Dietary supplement
OBSR is given orally once daily (3g) for 3 months
PlaceboOther
Placebo is given orally once daily (3g) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Omnibiotic Stress Repair (OBSR) | Active comparator | After randomisation, patients will receive a box with one sachet containing 3g of OBSR for each day. Receives: Dietary Supplement: Omnibiotic Stress Repair (OBSR) |
| Placebo | Placebo comparator | After randomisation, patients will receive an identical box with one sachet containing 3g of Placebo for each day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on disease activity according to PASDAS categories
To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients.
Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS > 3.2 - < 5.4) to low disease activity or remission (PASDAS ≤ 3.2) in the two groups.
Measured: 3 months
Secondary outcomes (27)
Effect on disease activity according to PASDAS score
To test differences in disease activity according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Effect on disease activity according to PASDAS categories independent of concomitant medication
To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients independent of the concomitant medication. For this analysis a logistic regression analysis will be performed using response as dependent and concomitant medication and OBSR/Placebo as indipendent variables.
Measured: 3 months
Longterm effect on disease activity according to PASDAS categories
To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) before and after probiotic intake at 3 and 6 months.
Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS > 3.2 - < 5.4) to low disease activity or remission (PASDAS ≤ 3.2) in the two groups.
Measured: 3 and 6 months
Impact of disease according to the PSAID-12
To assess differences in disease impact according to the Psoriatic Arthritis Impact of Disease Score - 12 (PSAID-12, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of disease according to the TJC
To assess differences in disease impact according to the Tender joint count (TJC, range 0-68, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of disease according to the SJC
To assess differences in disease impact according to the Tender joint count (SJC, range 0-66, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Pain assessed by PtPain VAS
To assess differences in pain measured by the patient pain visual analogue scale (Pt-VAS, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Enthesitis assessed by the LEI
To assess differences in enthesitis according to the leeds enthesitis index (LEI, range 0-6, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Dactylitis assessed by the DS
To assess differences in dactylitis according to the dactylitis score (DS, range 0-20, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of disease according to the PGA
To assess differences in disease impact according to the Patient global assessment (PGA, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of disease according to the EGA
To assess differences in physician's disease assessment according to the Evaluator global assessment (EGA, range 0-10, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of disease according to the SF-36
To assess differences in disease impact according to the Short form health survey 36 (SF-36, Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Dietary assessment according to the Diet-Questionnaire
To assess differences in diet according to the Diet-Questionnaire (15 questions on the type of diet and amount of food intake. Results will be depicted in a descriptive manner) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Skin involvement according to the PASI
To assess differences in skin involvement according to the Psoriasis Area and Severity Index (PASI, range 0-72, higher values indicating worse skin involvement) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of skin involvement according to the DLQI
To assess differences in quality of life due to skin involvement according to the Dermatology Life Quality Index (DLQI, range 0-30, higher values indicating worse quality of life) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Impact of disease according to the HAQ
To assess differences in disease impact according to the Health Assessment Questionnaire (HAQ, range 0-3, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Fatigue assessment accoring to the FACIT
To assess differences in fatigue according to the functional assessment of chronic illness therapy for fatigue (FACIT, range 0-52, higher values indicating worse fatigue) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Hospital anxietey and depression assessment according to the HADS
To assess differences in hospital anxietey and depression according to the Hospital Anxiety and Depression Scale (HADS, range 0-21, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Laboratory inflammation assessment according to ESR
To assess differences in disease impact according to the Erythrocyte sedimentation rate (ESR, mm, higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Laboratory inflammation assessment according to CRP
To assess differences in laboratory inflammation according to the C-reactive protein (CRP, mg/L. Higher values indicating worse status) before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Change in gut microbiota
To assess differences in gut microbiota composition (according to 16S rRNA targeted Amplicon Sequencing (%), displayed descriptively) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Gut permeability according to Zonulin
To assess differences in gut permeability according to stool Zonulin (ELISA, ng/ml, values above 55 indicate higher permeability) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Gut inflammation according to Calprotectin
To assess differences in gut inflammation according to stool Calprotectin (ELISA, mg/l, values above 50 indicate inflammation) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Neutrophile function according to Phagocytosis assessment
To assess differences in neutrophile function according to Phagocytosis assessment (Phagotest, normal values 95-99%, lower values indicate less function, Phagoburst, normal values 97-100% (E.coli stimulus), 1-10% (fMLP stimulus), 98-100% (PMA stimulus) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Inflammation assessment according to cytokine Level
To assess differences in cytokine levels in blood and synovial fluid (Interleukin (IL) pg/ml with normal ranges: IL-1 (<238), IL-5 (<19.27), IL-6 (<7.0), IL-8 (<10.59), IL-10 (<10.05), IL-17A (<11.14), IL-18 (37.43), IFN Alpha (<1.80), IFN Gamma (<6.82), TNF Alpha (<18.88)) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Lymphocyte subtypes according to FACS
To assess differences in lymphocyte subtypes according to fluorescence activated cell sorting (FACS, %) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Metabolic assessment using NMR
To assess metabolomic differences in stool, serum and synovial fluid using nuclear magnetic resonance (NMR metabolic profiling, results are shown in a descriptive manner) before and after probiotic intake and between the OBSR and placebo control before and after probiotic intake at 3 and 6 months and between the OBSR and placebo control group at 3 months.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start25 Nov 2020
- Primary completion12 Jan 2023
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588623
- Sponsor's protocol ID
- 32-347 ex 19/20
- Acronym
- MEDIPSA
- Status last verified
- Mar 2023
- First submitted
- 27 Jul 2020
- Last updated
- 16 Mar 2023
- Results posted
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotic Modulation of Enteral Dysbiosis on dIsease Activity in Patients With PSoriatic Arthritis
- ClinicalTrials.gov ID
- NCT04588623
- Acronym / sponsor ID
- MEDIPSA / 32-347 ex 19/20
- Conditions
- Psoriatic Arthritis
- Keywords
- psoriatic arthritis, probiotics, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 19 Oct 2020 (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 main purpose of this study is to validate the positive effect of "Omnibiotic Stress Repair" on patients with active psoriatic Arthritis.
Detailed description
This is a single center, double blind (patients and investigators), Placebo controlled randomized trial.
Consecutive patients with Psoriatic Arthritis (PsA) in moderate disease activity (Psoriatic Arthritis Disease Activity Score: PASDAS >3.2 - <5.4) on a stable treatment (no immunomodulatory treatment change in the last 3 months) with biological (bDMARDs) and/or synthetic disease modifying anti-rheumatic drugs (sDMARDs) and/or glucocorticoids will be included in the study. Clinical assessment will be scheduled at baseline, 12 weeks and 24 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnibiotic Stress Repair (OBSR) | Active comparator | Dietary Supplement: Omnibiotic Stress Repair (OBSR)After randomisation, patients will receive a box with one sachet containing 3g of OBSR for each day. |
| Placebo | Placebo comparator | Other: PlaceboAfter randomisation, patients will receive an identical box with one sachet containing 3g of Placebo for each day. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient ≥18 years and <90 years of age
- PsA according to CASPAR criteria
- MoDA defined by a PASDAS >3.2 - <5.4
- Stable immunomodulatory therapy for the last 12 weeks before baseline (no change in bDMARD/sDMARD/glucocorticoid treatment)
- Written informed consent
Key exclusion criteria (10 listed)
- History of bariatric surgery
- Prior use of probiotics in the last 24 weeks
- Use of probiotics, other than the study product, during the study period.
- Antibiotic therapy within the last 4 weeks before inclusion
- Inflammatory bowel disease
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 |
|---|---|---|
| Omnibiotic Stress Repair (OBSR)OBSR is given orally once daily (3g) for 3 months | Dietary supplement | Omnibiotic Stress Repair (OBSR) |
| PlaceboPlacebo is given orally once daily (3g) for 3 months | Other | Placebo |
Primary outcome
Effect on disease activity according to PASDAS categories
Time frame: 3 months
To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients. Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS > 3.2 - < 5.4) to low disease activity or remission (PASDAS ≤ 3.2) in the two groups.
27 secondary outcomes
Effect on disease activity according to PASDAS score
Time frame: 3 and 6 months
Effect on disease activity according to PASDAS categories independent of concomitant medication
Time frame: 3 months
Longterm effect on disease activity according to PASDAS categories
Time frame: 3 and 6 months
Impact of disease according to the PSAID-12
Time frame: 3 and 6 months
Impact of disease according to the TJC
Time frame: 3 and 6 months
Impact of disease according to the SJC
Time frame: 3 and 6 months
Pain assessed by PtPain VAS
Time frame: 3 and 6 months
Enthesitis assessed by the LEI
Time frame: 3 and 6 months
Dactylitis assessed by the DS
Time frame: 3 and 6 months
Impact of disease according to the PGA
Time frame: 3 and 6 months
Impact of disease according to the EGA
Time frame: 3 and 6 months
Impact of disease according to the SF-36
Time frame: 3 and 6 months
Dietary assessment according to the Diet-Questionnaire
Time frame: 3 and 6 months
Skin involvement according to the PASI
Time frame: 3 and 6 months
Impact of skin involvement according to the DLQI
Time frame: 3 and 6 months
Impact of disease according to the HAQ
Time frame: 3 and 6 months
Fatigue assessment accoring to the FACIT
Time frame: 3 and 6 months
Hospital anxietey and depression assessment according to the HADS
Time frame: 3 and 6 months
Laboratory inflammation assessment according to ESR
Time frame: 3 and 6 months
Laboratory inflammation assessment according to CRP
Time frame: 3 and 6 months
Change in gut microbiota
Time frame: 3 and 6 months
Gut permeability according to Zonulin
Time frame: 3 and 6 months
Gut inflammation according to Calprotectin
Time frame: 3 and 6 months
Neutrophile function according to Phagocytosis assessment
Time frame: 3 and 6 months
Inflammation assessment according to cytokine Level
Time frame: 3 and 6 months
Lymphocyte subtypes according to FACS
Time frame: 3 and 6 months
Metabolic assessment using NMR
Time frame: 3 and 6 months
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 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnibiotic Stress Repair (OBSR) in people with Psoriatic Arthritis, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 10 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 Mar 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 Austria. 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?
Effect on disease activity according to PASDAS categories (time frame: 3 months). 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 Mar 2023.