The MEDIPSA Clinical Trial

Medical University of Graz

Status: Completed

Conditions: Psoriatic Arthritis

Treatments: Other: Placebo; Dietary Supplement: Omnibiotic Stress Repair (OBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04588623

32-347 ex 19/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Omnibiotic Stress Repair (OBSR)

Active Comparator group

Description:

After randomisation, patients will receive a box with one sachet containing 3g of OBSR for each day.

Treatment:

Dietary Supplement: Omnibiotic Stress Repair (OBSR)

Placebo

Placebo Comparator group

Description:

After randomisation, patients will receive an identical box with one sachet containing 3g of Placebo for each day.

Treatment:

Other: Placebo