An Early Combined Microbiota and Metabolic Signature in Ulcerative Colitis Patients Predict the Clinical Success of Anti-inflammatory Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis
研究概览
简要总结
The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.
详细描述
The investigators perform a longitudinal prospective multi-center study for ulcerative colitis (UC) patients with a flare at/and after the time of starting a new treatment and healthy household controls. They will perform intense longitudinal bio-sampling and deep clinical characterization.
With this information the aim is to develop a predictive signature regarding the success of a new ly started anti-inflammatory therapy after an UC flare.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ulcerative colitis patients
Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
干预措施: Ozanimod (Drug)
Ulcerative colitis patients
Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
干预措施: TNF Inhibitor (Drug)
Ulcerative colitis patients
Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
干预措施: Steroids (Drug)
Ulcerative colitis patients
Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
干预措施: Vedolizumab (Drug)
Ulcerative colitis patients
Patients with a flare of ulcerative colitis who meet the inclusion criteria. 120 patients will be included.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis
时间窗: 4 months
The predictive microbiota signature will be developed using machine learning, considering clinical data, microbiota descriptors, and metabolic changes from day 0 to week 4 (see analysis). Clinical response will be defined as a decrease in the simple clinical colitis activity index (SCCAI) score by ≥3 points 25or to a level of ≤2.5 points 26 at 8 weeks after the start of anti-inflammatory treatment.
次要结局
- Predicting clinical remission(12 months)
- Differential microbiota response to therapy: TNF-inhibitors(12 months)
- Signature differences between ulcerative colitis and healthy controls(12 months)
- Differential microbiota response to therapy: Ozanimod(12 months)
- Predicting calprotectin reduction(12 months)
- Differential microbiota response to therapy: Ustekinumab(12 months)
- Adverse effects(12 months)
- Differential microbiota response to therapy: Vedolizumab(12 months)
- Differential microbiota response to therapy: Steroids(12 months)
- Metagenomic substrain assessment(12 months)
- Fatigue assessment(12 months)