Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rutgeerts score
研究概览
简要总结
The goal of this clinical trial is to learn if statins work to prevent strictures in adults with Crohn's disease. The main question it aims to answer is:
- Can statins reduce the formation of strictures in participants with stricturing Crohn's disease?
Researchers will compare statins to a placebo (a look-a-like substance that contains no drug) to see if statins work to prevent strictures from forming. Participants will:
- Take statins or a placebo every day for 6-12 months
- Visit the clinic for lab tests twice after starting either statins or placebo
- Complete questionnaires about symptoms and medications
- Respond to monthly check-ins (via phone call) during participation
详细描述
Strictures are a formidable complication of Crohn's disease (CD), with more than half of patients experiencing clinically significant bowel obstructions. Stricturing CD is a primary driver of morbidity and hospital admissions and is frequently associated with treatment failures. Moreover, it is estimated that nearly 50% of patients with CD will undergo bowel resection surgery within ten years of diagnosis, highlighting the severity and persistence of this issue for patients as well as the healthcare system.
By modulating inflammatory and fibrotic pathways, the investigators posit that statins reduce primary stricture development and also recurrence after stricture resection.
The investigators will assess the impact of statin therapy on early stricture recurrence in a pilot, randomized controlled clinical trial in patients undergoing stricture resection, evaluating both clinical outcomes and detailed immune, microbiome, and metabolic profiling. Through this effort, the investigators will determine if statins reduce clinical and biological signs of stricture recurrence in the short term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of stricturing Crohn's disease
- •Scheduled for surgical resection of terminal ileum strictures at either
- •Stanford University, or
- •Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles
排除标准
- •Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- •Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
- •Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- •Current use of cyclosporine
- •Current use of statin therapy prior to study initiation
- •Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
- •Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study:
- •Antifungals (e.g., ketoconazole, itraconazole, voriconazole)
- •Fibrate drugs
- •Macrolide antibiotics (e.g., erythromycin, clarithromycin)
- •Protease inhibitors (e.g., ritonavir, lopinavir)
- •Calcium channel blockers (e.g., verapamil, diltiazem)
- •Amiodarone
- •Colchicine
研究组 & 干预措施
Statin
Rosuvastatin tablet(s) once daily for 6-12 months. Dose will start at 10 mg daily (5 mg daily for Asians), then increase to 20 mg for those tolerating and without contraindication.
干预措施: Rosuvastatin (Drug)
Control
Placebo tablet(s) taken once daily for 6-12 months.
干预措施: Placebo (Other)
结局指标
主要结局
Rutgeerts score
时间窗: 6-12 months post surgery
Will be assessed at post surgery surveillance colonoscopy. Minimum score is i0 (no lesions) and maximum score is i4 (diffuse inflammation with already larger ulcers, nodules and/or narrowing), with higher scores meaning a worse outcome.
次要结局
未报告次要终点
研究者
Sidhartha Ranjit Sinha
Assistant Professor of Medicine
Stanford University