The MEDIPSA Clinical Trial
- Conditions
- Psoriatic Arthritis
- Registration Number
- NCT04588623
- Lead Sponsor
- Medical University of Graz
- Brief Summary
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
- Recent (less than 12 weeks) stroke
- Known malignancy
- Inability of the patient to follow the treatment protocol
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effect on disease activity according to PASDAS categories 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.
- Secondary Outcome Measures
Name Time Method Effect on disease activity according to PASDAS score 3 and 6 months 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.
Effect on disease activity according to PASDAS categories independent of concomitant medication 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 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.
Longterm effect on disease activity according to PASDAS categories 3 and 6 months 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.Impact of disease according to the PSAID-12 3 and 6 months 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.
Impact of disease according to the TJC 3 and 6 months 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.
Impact of disease according to the SJC 3 and 6 months 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.
Pain assessed by PtPain VAS 3 and 6 months 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.
Enthesitis assessed by the LEI 3 and 6 months 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.
Dactylitis assessed by the DS 3 and 6 months 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.
Impact of disease according to the PGA 3 and 6 months 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.
Impact of disease according to the EGA 3 and 6 months 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.
Impact of disease according to the SF-36 3 and 6 months 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.
Dietary assessment according to the Diet-Questionnaire 3 and 6 months 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.
Skin involvement according to the PASI 3 and 6 months 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.
Laboratory inflammation assessment according to CRP 3 and 6 months 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.
Change in gut microbiota 3 and 6 months 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.
Gut permeability according to Zonulin 3 and 6 months 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.
Gut inflammation according to Calprotectin 3 and 6 months 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.
Neutrophile function according to Phagocytosis assessment 3 and 6 months 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.
Inflammation assessment according to cytokine Level 3 and 6 months 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.
Lymphocyte subtypes according to FACS 3 and 6 months 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.
Metabolic assessment using NMR 3 and 6 months 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.
Impact of skin involvement according to the DLQI 3 and 6 months 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.
Impact of disease according to the HAQ 3 and 6 months 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.
Fatigue assessment accoring to the FACIT 3 and 6 months 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.
Hospital anxietey and depression assessment according to the HADS 3 and 6 months 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.
Laboratory inflammation assessment according to ESR 3 and 6 months 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.
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Styria, Austria
Medical University of Graz🇦🇹Graz, Styria, Austria