The MEDIPSA Clinical Trial

NCT04588623 | Completed

• 1 other identifier: 32-347 ex 19/20
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriatic Arthritis

Keywords

psoriatic arthritis; probiotics; microbiome

Outcome Measures

Primary Outcomes (1)

• Effect on disease activity according to PASDAS categories

  To test differences in response according to the Psoriatic Disease Activity Score (PASDAS, range 0-10, higher values indicate higher disease activity) after 3 months of intake of OBSR compared to placebo in PsA patients. Difference in response is defined by the different amount of patients shifting from moderate disease activity (PASDAS \> 3.2 - \< 5.4) to low disease activity or remission (PASDAS ≤ 3.2) in the two groups.

  3 months

Secondary Outcomes (27)

• Effect on disease activity according to PASDAS score

  3 and 6 months

• Effect on disease activity according to PASDAS categories independent of concomitant medication

  3 months

• Longterm effect on disease activity according to PASDAS categories

  3 and 6 months

• Impact of disease according to the PSAID-12

  3 and 6 months

• Impact of disease according to the TJC

  3 and 6 months

Study Arms (2)

Omnibiotic Stress Repair (OBSR)

ACTIVE COMPARATOR

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

Dietary Supplement: Omnibiotic Stress Repair (OBSR)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Omnibiotic Stress Repair (OBSR) DIETARY_SUPPLEMENT

OBSR is given orally once daily (3g) for 3 months

Omnibiotic Stress Repair (OBSR)

Placebo OTHER

Placebo is given orally once daily (3g) for 3 months

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: October 19, 2020
• Study Start: November 25, 2020
• Primary Completion: January 12, 2023
• Study Completion: March 14, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)