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The MEDIPSA Clinical Trial

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 89 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04588623
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Medical University of Graz
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Austria
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Omnibiotic Stress Repair (OBSR)

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

Placebo Comparator: Placebo

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Medical University of Graz, Graz, Styria, Austria

Status

Recruiting

Address

Medical University of Graz

Graz, Styria, 8010

Site Contact

Martin Stradner, MD

martin.stradner@medunigraz.at

+4331638517779

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