Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease (XENIC): an Open-label, Multicenter, Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Percentage of participants with mucosal healing
研究概览
简要总结
Inflammatory bowel diseases are chronic and progressive entities, triggered by exposure to environmental factors in individuals with a genetic background.
One of the most common environmental factors is the type of diet which is a key influencer on pathogenesis. Nutrients alter the intestinal microbiota, thus changing the intestinal permeability. The Western-type diet encompasses sugar, fat, and protein-rich products that have some deleterious effects on the intestinal microbiome compared to the plant-based Mediterranean-type diet.
Based on this fact, diet-based therapeutic efforts have been used extensively in pediatric Crohn's disease patients and there is strong evidence that exclusive enteral nutrition (EEN) is as effective as corticosteroids to induce both clinical and endoscopic remission but this treatment strategy is underutilized in adults.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, aged between 18-75 years with a diagnosis of ileocolonic Crohn's disease (CD) confirmed using endoscopy and/or imaging technology at most 3 months prior.
- •Participant or his/her legal representative have voluntarily signed and dated an informed consent approved by and compliant with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Adequate cardiac, renal, and hepatic function as determined by the Principal Investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that do not indicate an abnormal clinical condition that would place the participant at undue risk preclude participation in the study.
- •Participant must be able to orally administer study medication/nutrient or have a designee or Healthcare Professional who can assist
排除标准
- •Previous or current use of any medication for Crohn's disease such as biologics, immunomodulators (e.g., methotrexate, azathioprine, 6-mercaptopurine, JAK inhibitor, alpha-integrin), and corticosteroids
- •Presence of complications (Fistula, abscess, fibrotic disease, imminent risk of surgery)
- •Participants with a poorly controlled medical condition such as uncontrolled diabetes with a documented history of recurrent infections, unstable ischemic heart disease, moderate to severe congestive heart failure (New York Heart Association [NYHA] class III or IV), recent cerebrovascular accident, and any other condition which, in the opinion of the Investigator or the sponsor, would put the participant at risk by participation in the protocol
- •Participants with positive C. difficile stool assay at screening.
- •Rescue therapy with steroids, depending on the severity of the disease will be initiated for patients in the EEN group who do not respond clinically and will be excluded from the study. If the number of clinically unresponsive patients was greater than 25% of the total EEN population, the study will be stopped. Criteria for clinical response are described in the "Outcome Measures" section.
研究组 & 干预措施
Exclusive Enteral Nutrition
35kcal/kg/day EEN (Nestle Modulen®) - Subjects will take medicine and EEN solution orally themselves.
干预措施: EEN (Nestle Modulen®) (Dietary Supplement)
Standard of care
- Budesonide 9mg/day for mild disease
- Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks.
- Patients with moderate-to-severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine.
干预措施: Standart of care (Drug)
结局指标
主要结局
Percentage of participants with mucosal healing
时间窗: 12 weeks
Defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) ≤2, at 12 weeks after randomization. The ileocolonoscopies will be evaluated by the site. SES-CD is an index for determining the severity of Crohn's disease. The SES-CD considers size of ulcerations, ulcerated surface, effected surface and the presence of narrowings, evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 60 where higher scores indicate more severe endoscopic activity.
Percentage of patients that tolerate the EEN by week 12
时间窗: 12 weeks
Defined as withdrawal from the study from randomization through 12 weeks after randomization
次要结局
- Mean change from baseline in SES-CD at 12 weeks after randomization(12 weeks)
- Mean change from baseline in C-reactive protein (CRP) over time (Time Frame: 4, 8 and 12 weeks after randomization)(12 weeks)
- Mean change from baseline in fecal calprotectin (FC) over time (Time Frame: 4, 8 and 12 weeks after randomization)(12 weeks)
- Endoscopic response(12 weeks)
- Mean change from baseline in CDAI over time (Time Frame: Baseline, 4, 8 and 12 weeks after randomization)(12 weeks)
- Change in Robarts Histopathology Index (RHI) (Time Frame: Baseline and 12 weeks after randomization)(12 weeks)
- Number of Crohn's disease-related hospitalizations after randomization (Time Frame: From randomization through 12 weeks after randomization)(12 weeks)
- Time to clinical remission (Time frame: from randomization through 12 weeks after randomization)(12 weeks)
- Time to clinical response (Time frame: from randomization through 12 weeks after randomization)(12 weeks)
- Mean change from baseline in PRO-2 (Time Frame: Baseline and 12 weeks after randomization)(12 weeks)
- Change from baseline in SIBDQ total score (Time Frame: Baseline and 12 weeks after randomization)(12 weeks)
研究者
Salih Tokmak
Asistant Professor
Duzce University