NL-OMON53395招募中不适用
Prospective rAndomized controlled tRial of Crohn*s diseAse exclusion Diet vs corticosteroIds in patientS with activE Crohn*s disease - PARADISE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16 至 99（—）
入选标准
- •- Patients aged 16 to 70 years,
- •- With mild to moderate, luminal, active CD, defined by a HBI of 5 to 16,
- •involving the small bowel, and/or the colon
- •- Not treated with corticosteroids at baseline
- •- Patients either naïve or previously exposed to a maximum of two classes of
- •biologics or currently receiving a biologic therapy, and exposed to a maximum
- •of two classes of biologic therapy, including the current one
- •- Patent small bowel as assessed by the patency capsule
- •- Active endoscopic lesions, as defined by Lewis score >= 225 in the small bowel
- •and/or SES-CD>= 4 in the colon. The eligibility of the patient will be
- •determined by the site investigator and a central reader.
排除标准
- •- Inability to follow the CDED during 16 weeks.
- •- Prior intolerance to corticosteroids.
- •- Ongoing infections, evolving virus diseases.
- •- Live vaccines.
- •- Arthritis or uveitis as main presenting symptoms.
- •- Patients with severe and/or predominant rectal or perianal disease.
- •- Heavy smokers (more than 10 cigarettes per day).
- •- Infliximab, adalimumab, methotrexate or azathioprine initiated less than 3
- •months before inclusion in this trial.
- •- Vedolizumab, ustekinumab initiated less than 6 months before inclusion in
- •this trial.
- •- Change in methotrexate, azathioprine, infliximab, adalimumab, vedolizumab or
- •ustekinumab dosage less than 3 months before inclusion.
- •- Pregnant or lactating women
研究者
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