The MEDIPSA Clinical Trial

Psoriatic Arthritis Clinical Trial

— MEDIPSA  

Official title:

The Effect of Probiotic Modulation of Enteral Dysbiosis on dIsease Activity in Patients With PSoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588623
• Other study ID #: 32-347 ex 19/20
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: March 14, 2023

Study information

• Verified date: March 2023
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 14, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Dietary Supplement:
• Omnibiotic Stress Repair (OBSR)
OBSR is given orally once daily (3g) for 3 months

Other:
• Placebo
Placebo is given orally once daily (3g) for 3 months

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 and 6 months
Secondary	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.	3 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months
Secondary	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.	3 and 6 months