Trials / Completed
CompletedNCT04588623
The MEDIPSA Clinical Trial
The Effect of Probiotic Modulation of Enteral Dysbiosis on dIsease Activity in Patients With PSoriatic Arthritis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Medical University of Graz · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-11-25
- Primary completion
- 2023-01-12
- Completion
- 2023-03-14
- First posted
- 2020-10-19
- Last updated
- 2023-03-16
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04588623. Inclusion in this directory is not an endorsement.