Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 89 Years|
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.
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Medical University of Graz|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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.
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
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Martin H Stradner, MD
For additional contact information, you can also visit the trial on clinicaltrials.gov.