Prospective rAndomized Controlled tRial of Crohn's diseAse Exclusion Diet vs corticosteroIds in patientS With activE Crohn's Disease - PARADISE
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Endoscopic response W16
研究概览
简要总结
Crohn's disease exclusion diet (CDED) is a whole-food diet coupled with partial enteral nutrition. The main objective of this trial is to assess whether CDED is superior to corticosteroids, in terms of endoscopic response, in patients active CD. The primary endpoint is endoscopic response at week 16, without corticosteroids or further therapeutic intervention, assessed by a centralized, anonymous and blinded, double lecture panel of panenteric PillCam Crohn's Capsule. This is a multicentre, open-label, comparative, randomized, 2:1, controlled, single-blind, superiority trial. Patients included are aged 16 to 70 years, have mild to moderate, luminal, active CD, and have active endoscopic lesions. Eighty patients will be randomized between CDED (n=56) and corticosteroids (n=24) in centres in France, Israel and the Netherlands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 16 to 70 years,
- •With mild to moderate, luminal, active CD, defined by a CDAI of 150 to 350,
- •Involving the small bowel, and/or the colon
- •Not treated with corticosteroids at baseline
- •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.
- •Informed consent to participate in this study. In patients from France and Israel who are aged less than 18: parents' informed consent to participate in this study (parents' agreement is not required in patients aged 16 to 18 in the Netherlands)
- •Affiliation to social security or any health insurance
排除标准
- •Inability to follow the CDED during 16 weeks.
- •Prior intolerance to corticosteroids.
- •Ongoing infections, evolving virus diseases.
- •Live vaccines.
- •Psychotic state not controlled by treatment.
- •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.
- •Patients already included in a biomedical research other than an observational study (e.g. registry, cohort, biobank).
- •Severe pubertal delay (Tanner 1 or Tanner 2) and/or height velocity z-score < 2.5 and/or Bone mineral density z-score (hip or lumbar spine) <2.
- •Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under sections L.3212-1 et L.3213-1 and persons admitted to a health or social institution for purposes other than research (L.1121-6)
研究组 & 干预措施
Crohn's disease exclusion diet (CDED)
16-week course of Crohn's disease exclusion diet (CDED) and Partial Enteral Nutrition.
干预措施: Crohn's disease exclusion diet (CDED) (Dietary Supplement)
Steroids
oral prednisolone at an initial dose of 40 to 60 mg/day.
干预措施: Oral prednisolone (Drug)
结局指标
主要结局
Endoscopic response W16
时间窗: Week 16
The primary endpoint is the endoscopic response at week 16, assessed by Panenteric capsule (PillCam Crohn's capsule) using centralized, anonymous and blinded reading of PCC. The response is defined as a single binary endpoint according to the initial strata of the patient: * Small bowel Crohn's diseAse (CD) : decrease of the Lewis score of at least 50% compared to baseline values * Colonic CD : decrease of SES-CD of at least 50% compared to baseline values * Small bowel and colonic CD : decrease of the Lewis score of at least 50% AND decrease of SES-CD of at least 50% compared to baseline values. Lewis score : Gralnek IM, Defranchis R, et al. Development of a capsule endoscopy scoring index for small bowel mucosal inflammatory change. Aliment Pharmacol Ther 2008; 27: 146-154. SES-CD : Daperno M, D'Haens G, et al . Development and validation of a new, simplified endoscopic activity score for Crohn's disease: the SES-CD. Gastrointest Endosc 2004; 60 (4): 505-512.
次要结局
- Decrease of fecal calprotectin concentration(Week 16 and Week 48)
- Rate of Need for further therapeutic intervention(Week 48)
- Rate of Fecal calprotectin below thresholds(Week 16)
- Value Work(Week 6 and Week 16)
- Rate of Clinical response(Week 16 and Week 48)
- Rate of adherence using food diaries(Week 1, Week 9 and Week 16)
- Rate of Clinical remission(Week 16 and Week 48)
- Rate of normal CRP concentration(Week 16 and Week 48)
- Rate of Endoscopic response(Week 16)
- Gut microbiota composition(Week 6 and Week 16)
- Value of adherence by Medication Adherence Report Scale(Week 1, Week 9 and Week 16)
- Rate of Endoscopic remission(Week 16)
- Value of Quality of life(Week 3, Week 6 and Week 16)