Influence of the short-chain fatty acid propionate as a metabolic product of the human gut microbiome in the context of arthritic diseases

Not Applicable

Recruiting

• Conditions: Psoriasis Psoriatic arthritisRheumatoid arthritisAnkylosing SpondylitisHealthy controls

• Registration Number: DRKS00023985
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

General criteria (valid for all participants)
- Adults, male or female, capable of giving consent.
- Age 18 - 80 years
- Present informed consent to participate in the study

(Group 1) Healthy subjects
o Clinical and medical history: no arthritis, no psoriasis
o Serological: ACPA negative, RF negative
o Exclusion: diagnosis of a chronic inflammatory disease
o Exclusion: use of immunosuppressive therapy (csDMARD, bDMARD, tsDMARD)

Disease-specific inclusion criteria:
- (Group 2) Rheumatoid arthritis
o Classification according to the ACR/EULAR 2010 classification criteria
o Duration of disease: no restriction
o Therapy: no restriction of immunosuppressive therapy
o Disease activity: no restriction
- (Group 3) Rheumatoid arthritis at risk
o No classification according to ACR/EULAR 2010 classification criteria
o Detection of ACPA-AK for screening purposes
o Disease activity: no arthritis/synovitis in the 66/68 joint count at screening and baseline
- (Group 4) Psoriasis vulgaris and/or palmo-plantaris
o Diagnosis confirmed histologically or by a specialist (dermatology/rheumatology)
- (Group 5) Psoriatic arthritis
o Classification according to CASPAR classification criteria
o Duration of disease: no restriction
o Therapy: no limitation of immunosuppressive therapy
o Disease activity: no restriction
- (Group 6) Ankylosing spondylitis
o Classification according to ASAS classification criteria
o Duration of disease: no restriction
o Therapy: no restriction of immunosuppressive therapy
o Disease activity: no restriction

Exclusion Criteria

none

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of regulatory T cells (Tregs) (% CD4+, CD25+, FoxP3+) to total T cells (Tg, CD4+).<br><br>Number of subjects with a 50% improvement in the Tregs/Tg quotient in peripheral blood after 28 days of treatment.