DRKS00023985招募中未知
Influence of the short-chain fatty acid propionate as a metabolic product of the human gut microbiome in the context of arthritic diseases - ProDarMi
niversitätsklinikum Erlangen0 个研究点目标入组 180 人开始时间: 2020年12月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- 未提供
研究者
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