NCT06279065招募中不适用
Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Significant differences in the composition of the microbiome
研究概览
简要总结
The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (abbr. GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate biota will be further analyzed for possible interactions and influence on the immune system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Giant cell arteritis (only in one arm)
排除标准
- •chronic infection (viral, fungi, bacteria) including human immunodeficiency viruses, Hepatitis B/C
- •acute infection with usage of antibiotics less then 90 days before screening
- •major gastro-intestinal surgery <5 years from screening
- •gastro-intestinal bleeding <90 days before screening
- •inflammatory bowel disease (confirmed bioptically)
- •bulimia or anorexia nervosa
- •adipositas (body mass index ≥ 40)
- •intake of high dosage of probiotics (>10^9 colony forming units per day) <90 days before screening
- •not controlled Diabetes mellitus
- •Malignancy within one year (except for squamous skin - and basal skin carcinoma without metastasis, cervix carcinoma with curative surgery, Cutaneous T-cell lymphoma)
- •known abuse of alcohol oder drugs.
结局指标
主要结局
Significant differences in the composition of the microbiome
时间窗: At Baseline and 6 month follow up
次要结局
- Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species(At Baseline and 2 year follow up)
- potential association of microbiome composition with application of immune modulating drugs(At Baseline and 6 month follow up)
研究者
Valentin Schäfer
Head of the rheumatology department, University Hospital Bonn
University of Bonn
研究点 (2)
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