The MEDIPSA Clinical Trial

Medical University of Graz66 enrolled

Overview

The main purpose of this study is to validate the positive effect of "Omnibiotic Stress Repair" on patients with active psoriatic Arthritis.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Psoriatic Arthritis

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patient ≥18 years and \<90 years of age 2. PsA according to CASPAR criteria 3. MoDA defined by a PASDAS \>3.2 - \<5.4 4. Stable immunomodulatory therapy for the last 12 weeks before baseline (no change in bDMARD/sDMARD/glucocorticoid treatment) 5. Written informed consent Exclusion Criteria: 1. History of bariatric surgery 2. Prior use of probiotics in the last 24 weeks 3. Use of probiotics, other than the study product, during the study period. 4. Antibiotic therapy within the last 4 weeks before inclusion 5. Inflammatory bowel disease 6. Recent (less than 12 weeks) acute myocardial infarction or decompensated heart failure 7. Recent (less than 12 weeks) stroke 8. Known malignancy 9. Inability of the patient to follow the treatment protocol 10. Pregnancy

Locations (1)

Medical University of Graz

Graz, Styria, Austria

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 3 and 6 months

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 and 6 months