The MEDIPSA Clinical Trial

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    74
  • sponsor
    Medical University of Graz
Updated on 28 March 2021

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.

Details
Condition Psoriasis, Psoriasis and Psoriatic Disorders, PSORIATIC ARTHRITIS, PSORIATIC ARTHRITIS, Arthritis, Arthritis and Arthritic Pain, Arthritis and Arthritic Pain (Pediatric), Arthritis and Arthritic Pain, Psoriasis and Psoriatic Disorders, Arthritis and Arthritic Pain (Pediatric)
Treatment Placebo, Omnibiotic Stress Repair (OBSR)
Clinical Study IdentifierNCT04588623
SponsorMedical University of Graz
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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