A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects With Crohn's Disease (CD) Receiving Anti-TNF Therapy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 39
- 主要终点
- Simple Endoscopic Score - Crohn's Disease (SES-CD)
研究概览
简要总结
The purpose of this study is to evaluate CROWN's efficacy in supporting the repair and maintenance of the intestinal mucosa of patients with moderately to severely active Crohn's Disease receiving anti-Tumor Necrosis Factor (TNF) therapy (infliximab, adalimumab, certolizumab)
详细描述
The purpose of this study is to evaluate the effectiveness of an orally administered nutritional intervention (CROWN) in subjects with Crohn's Disease (CD) to support Standard Of Care (SOC) treatment in the repair and maintenance of the intestinal mucosa over a 24 week period. SOC is defined as having been on a stable maintenance dose of an anti-Tumor Necrosis Factor (TNF) agent within 24 weeks of its initiation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's Disease patient who has derived clinical benefit from the Standard of Care therapy, but continues to have evidence of incomplete healing of the intestinal mucosa.
- •Adults (18-85 years of age) with a known history of symptomatic CD confirmed by endoscopy or radiology
- •CDAI score ≤ 350
- •Active endoscopic disease (SES-CD score ≥ 6) documented during the study screening phase or SES-CD score ≥ 4 if isolated ileal disease
- •On a stable dose of infliximab, adalimumab, or certolizumab therapy for 8 weeks prior to randomization as part of SOC
- •Able to consume oral nutrition for up to 24 weeks consisting of two 4 oz (120 ml) servings daily
- •Able to understand the informed consent process, willing to follow study instructions and likely to complete all required visits and procedures, including the use of an electronic device to collect study data, home computer or tablet and internet access to complete online food frequency questionnaire, and undergo 2 endoscopies in a 6 month period
排除标准
- •Subjects with one or more of the following criteria are excluded from participation in the study:
- •If female, subject is pregnant, nursing, or planning to become pregnant during the study period or is of childbearing potential and unable or unwilling to use a reliable form of contraception during the study
- •Fistula known to be contributing to diarrhea
- •Recent or current history of bowel obstruction
- •Stricturing disease with evidence of bowel dilation proximal to stricture on imaging
- •Anticipated need for gastrointestinal surgical therapy in the next 6 months
- •Current treatment with a systemic corticosteroid at dose greater than 20 mg of prednisone (or equivalent) at screening
- •Change in any antimetabolite therapy within 8 weeks prior to randomization
- •Current treatment with antibiotics for CD (ciprofloxacin, metronidazole) at screening
- •Current ostomy
- •Serious infection, neoplasia or other medical conditions which would interfere with participation in the study, in the opinion of the Investigator
- •Evidence of Clostridium difficile infection in the previous 4 weeks
- •History of non-compliance with clinical protocols
- •Active participation in another CD trial or received an investigational product within the past 4 weeks
- •Diagnosis of celiac disease
- •Known sensitivity to milk or soy protein
- •In the Investigator's opinion, subject has any condition or situation which makes the subject unsuitable for study participation, may put the subject at significant risk, or may confound the study results
研究组 & 干预措施
CROWN
CROWN: A nutritionally based therapy with a high protein content, formulated as a powder. Twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
干预措施: CROWN (Drug)
CROWN Placebo
Placebo: An appearance and volume matched formulated powder. Twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
干预措施: CROWN Placebo (Drug)
结局指标
主要结局
Simple Endoscopic Score - Crohn's Disease (SES-CD)
时间窗: Week 24
Measuring intestinal health improvement is the Week 24 change from baseline in Simple Endoscopic Score - Crohn's Disease (SES-CD)
次要结局
- Plasma amino acid level(Week 12 and at Week 24)
- Quality of Life Score - Inflammatory Bowel Disease Questionnaire (IBDQ)(Weeks 12 and 24)
- Quality of Life Score - Work Productivity Activity Index - Crohn's Disease(WPAI-CD)(Weeks 12 and 24)
- Inflammatory biomarkers(Week 24)
- Endoscopic response(Week 24)
- Corticosteroid-free(Week 12)