A Randomized, Controlled Trial Investigating the Efficacy of Palmitoleic Acid Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Complete mucosal healing
研究概览
简要总结
This study aims to evaluate whether the combination of palmitoleic acid with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.
详细描述
This is a prospective, randomized, controlled, open-label clinical study designed to evaluate the efficacy of palmitoleic acid combined with infliximab in patients with Crohn's disease.
Eligible patients will be randomly assigned to receive either intravenous infliximab at standard clinical doses plus daily oral palmitic acid supplementation, or intravenous infliximab alone. The primary endpoint is complete mucosal healing at Week 26. Secondary endpoints include endoscopic remission, endoscopic response, clinical remission and clinical response at Week 26.
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
- •Adult patients aged 18 to 75 years.
- •Established diagnosis of Crohn's disease confirmed by radiologic, histologic, or endoscopic evidence.
- •Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive).
- •Adequate cardiac, renal, and hepatic function, as assessed by the investigator based on screening laboratory tests, physical examination, and medical history, without findings that would pose an undue risk for study participation.
- •Willingness and ability to provide written informed consent.
- •Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations.
排除标准
- •Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening.
- •Use of supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 8 weeks prior to screening.
- •History of any intestinal resection or other Crohn's disease-related surgery.
- •History of or active chronic or recurrent infectious disease.
- •History of or current malignancy.
- •Pregnancy, lactation, or intention to become pregnant during the study period.
- •Known hypersensitivity to infliximab or palmitoleic acid preparations.
研究组 & 干预措施
Palmitoleic Acid + Infliximab
干预措施: Palmitoleic Acid + Infliximab (Drug)
Infliximab alone
干预措施: Infliximab (Drug)
结局指标
主要结局
Complete mucosal healing
时间窗: From enrollment to the end of treatment at 26 weeks
Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.
次要结局
- Endoscopic remission(From enrollment to the end of treatment at 26 weeks)
- Endoscopic response(From enrollment to the end of treatment at 26 weeks)
- Clinical remission(From enrollment to the end of treatment at 26 weeks)
- Clinical response(From enrollment to the end of treatment at 26 weeks)
研究者
Sheng-hong Zhang
Chief Physician, Professor
Chinese Medical Association