A Randomized Controlled Study to Evaluate the Efficacy of Enteral Nutrition Biscuits in Inducing Remission in Moderate to Severe Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 主要终点
- Crohn's disease activity index, CDAI
研究概览
简要总结
By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions.
详细描述
This project is a randomized controlled study evaluating the effects of enteral nutrition biscuits during the induction and remission phases of moderate to severe Crohn's disease. The study subjects were patients with moderate to severe Crohn's disease, and the control group received conventional treatment with existing drugs; The experimental group added oral enteral nutrition biscuits to intervene on the basis of existing drugs. Evaluate the clinical response rates of patients at 2, 4, 8, 12, and 24 weeks after intervention; Nutritional status before and after intervention, incidence and severity of perianal lesions, and remission rate of small intestine and colon lesions.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years old, gender is not limited
- •Patients with a combination of clinical manifestations, laboratory examinations, endoscopy, imaging examinations and histopathological examinations to diagnose Crohn's disease for at least 6 months
- •Patients with Crohn's disease with a CDAI score of > 220 and an HBI of ≥5
- •Voluntarily signed written informed consent
排除标准
- •Patients with newly diagnosed Crohn's disease, no history of treatment with 5-aminosalicylic acid, biological or immunological agents
- •Current presence of an abscess or suspected abscess
- •Positive results of stool culture or other intestinal pathogens
- •Use of any antibiotics, prebiotics, probiotics, nutrition bars and enteral nutrition in the past 4 weeks
- •Known hypersensitivity to any of the components administered in this study
- •Severe infection (CTC AE> grade 2) within 4 weeks prior to the start of the study
- •Patients who have recently undergone digestive surgery (< 1 month) or have not been completely cured
- •Patients with severe gastrointestinal problems (such as life-threatening intestinal obstruction, perforation, and bleeding) requiring immediate treatment
- •Have an underlying medical condition that affects treatment
- •Pregnant or lactating women
- •Positive for human immunodeficiency virus
- •Known history of active pulmonary tuberculosis. Subjects with suspected active tuberculosis should be examined for chest x-ray, sputum, and exclusion by clinical signs and symptoms
- •Patients with untreated chronic hepatitis B or hepatitis B virus carriers with chronic hepatitis B virus DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Patients with inactive HBsAg, treated and stable hepatitis B patients (HBV DNA <500 IU/mL), and cured hepatitis C patients may be enrolled. Subjects with positive hepatitis C virus antibodies are eligible to participate in the study only if they have a negative HCV RNA test result
- •Known history of psychotropic substance abuse, alcoholism, and drug abuse
- •Any condition that, in the opinion of the investigator, the participant should be excluded from the study
结局指标
主要结局
Crohn's disease activity index, CDAI
时间窗: 2、4、8、12、24 weeks after intervention
Assessment was performed using the Crohn's disease activity index (CDAI), with a clinical response defined as a CDAI score \<150.
次要结局
- Incidence and severity of perianal lesions in both groups(1、8、24 weeks after intervention)
- Gastrointestinal symptom remission(4 weeks after intervention)
- Rate of endoscopic remission of small bowel and colon lesions in both groups(1、8、24 weeks after intervention)
- Gastrointestinal Symptom Rating Scale (GSRS) score(2、4、8、12、24 weeks after intervention)
- Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0(1、4、8、12、24 weeks after intervention)
- Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups(1、4、8、12、24 weeks after intervention)
- Induced remission success rate(2、4、8、12、24 weeks after intervention)
- Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics(1、4、8、12、24 weeks after intervention)
研究者
Ping An
Professor
Renmin Hospital of Wuhan University