Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Placebo, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 196
- 试验地点
- 6
- 主要终点
- The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
研究概览
简要总结
The goal of this clinical trial is to investigate the efficacy of ursodeoxycholic acid in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of ursodeoxycholic acid. The main questions it aims to answer are:
Does ursodeoxycholic acid promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking ursodeoxycholic acid? Researchers will compare ursodeoxycholic acid to a placebo (a look-alike substance that contains no drug) to see if ursodeoxycholic acid is effective in treating gastric intestinal metaplasia.
Participants will:
Take ursodeoxycholic acid or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.
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
- Double (Participant, Investigator)
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
- •patients aged from 18 to 75 years old.
- •patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.
- •patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.
排除标准
- •a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and/or statins.
- •a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.
- •a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.
- •breastfeeding or pregnancy.
- •a history of substance abuse or alcohol abuse within the past one year.
- •patients with severe mental illness.
- •refusal to undergo drug treatment.
- •refusal to sign informed consent.
研究组 & 干预措施
The ursodeoxycholic acid group
Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.
干预措施: Ursodeoxycholic Acid (Drug)
The placebo group
Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.
干预措施: Placebo (Drug)
结局指标
主要结局
The regression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
时间窗: From enrollment to the end of treatment at 6 months
Regression was defined as a OLGIM stage decreased at least one grade.
The progression rate of gastric intestinal metaplasia based on OLGIM stage in different groups.
时间窗: From enrollment to the end of treatment at 6 months
Progression was defined as a OLGIM stage increased at least one grade.
次要结局
- The regression rate of gastric atrophy based on OLGA stage in different groups.(From enrollment to the end of treatment at 6 months)
- The progression rate of gastric atrophy based on OLGA stage in different groups.(From enrollment to the end of treatment at 6 months)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases