The Preventative and Therapeutical Effect of Ursodeoxycholic Acid(UDCA) to Parenteral Nutrition-associated Cholestasis in Short Bowel Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The biochemical indicator of patients' liver function during oral UDCA or placebo
研究概览
简要总结
The efficacy of UDCA in treating the parenteral nutrition-associated cholestasis(PNAC) has been identified by some studies in children without short bowel syndrome(SBS).Most of the adults who suffering PNAC have SBS. it limits the potential function of UDCA because of the lack of SBS patients and malabsorption of UDCA.Therefore, we design this clinical trial in our center of SBS to approach the preventative and therapeutical effect of UDCA to PNAC in adults with short bowel syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with short bowel syndrome supported by total parenteral nutrition.
- •Patients have intestine more than 50cm.
- •Requirements of informed consent and assent of participant, parent or legal guardian as applicable
- •Consciousness and ability to cooperate.
排除标准
- •Patients have obstruction of biliary tract, infection, autoimmune disease, cancer
- •Patients have intestine less than 50cm
- •A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
- •Female with positive pregnancy
- •Allergy to ursodeoxycholic acid
研究组 & 干预措施
UDCA+placebo group
15-30mg/kg/d UDCA for 2 months + placebo for 2 months
干预措施: ursodeoxycholic acid (Drug)
placebo+UDCA
placebo for 2 months+15-30mg/kg/d UDCA for 2 months
干预措施: ursodeoxycholic acid (Drug)
结局指标
主要结局
The biochemical indicator of patients' liver function during oral UDCA or placebo
时间窗: 2 months
detect the biochemical indicator of patients' liver function(Serum bilirubin, GGT Valley, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase) during oral UDCA or placebo
次要结局
- the changs of composition of serum bile acid after oral UDCA or placebo(2 months)
- The changs of the level of fibroblast growth factor 19(FGF19) in the serum(4 months)
研究者
Kong Wencheng
Senior Resident
Jinling Hospital, China