Clinical trial NCT04588623: The MEDIPSA Clinical Trial
Official title: The Effect of Probiotic Modulation of Enteral Dysbiosis on dIsease Activity in Patients With PSoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis
probiotics
microbiome
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect on disease activity according to PASDAS categories
timeFrame: 3 months
Secondary outcomes:
measure: Effect on disease activity according to PASDAS score
timeFrame: 3 and 6 months
measure: Effect on disease activity according to PASDAS categories independent of concomitant medication
timeFrame: 3 months
measure: Longterm effect on disease activity according to PASDAS categories
timeFrame: 3 and 6 months
measure: Impact of disease according to the PSAID-12
timeFrame: 3 and 6 months
measure: Impact of disease according to the TJC
timeFrame: 3 and 6 months
measure: Impact of disease according to the SJC
timeFrame: 3 and 6 months
measure: Pain assessed by PtPain VAS
timeFrame: 3 and 6 months
measure: Enthesitis assessed by the LEI
timeFrame: 3 and 6 months
measure: Dactylitis assessed by the DS
timeFrame: 3 and 6 months
measure: Impact of disease according to the PGA
timeFrame: 3 and 6 months
measure: Impact of disease according to the EGA
timeFrame: 3 and 6 months
measure: Impact of disease according to the SF-36
timeFrame: 3 and 6 months
measure: Dietary assessment according to the Diet-Questionnaire
timeFrame: 3 and 6 months
measure: Skin involvement according to the PASI
timeFrame: 3 and 6 months
measure: Impact of skin involvement according to the DLQI
timeFrame: 3 and 6 months
measure: Impact of disease according to the HAQ
timeFrame: 3 and 6 months
measure: Fatigue assessment accoring to the FACIT
timeFrame: 3 and 6 months
measure: Hospital anxietey and depression assessment according to the HADS
timeFrame: 3 and 6 months
measure: Laboratory inflammation assessment according to ESR
timeFrame: 3 and 6 months
measure: Laboratory inflammation assessment according to CRP
timeFrame: 3 and 6 months
measure: Change in gut microbiota
timeFrame: 3 and 6 months
measure: Gut permeability according to Zonulin
timeFrame: 3 and 6 months
measure: Gut inflammation according to Calprotectin
timeFrame: 3 and 6 months
measure: Neutrophile function according to Phagocytosis assessment
timeFrame: 3 and 6 months
measure: Inflammation assessment according to cytokine Level
timeFrame: 3 and 6 months
measure: Lymphocyte subtypes according to FACS
timeFrame: 3 and 6 months
measure: Metabolic assessment using NMR
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References: