CLINICAL TRIAL: A PHASE II TRIAL OF URSODEOXYCHOLIC ACID (UDCA) THERAPY FOR BILI

临床试验：熊去氧胆酸 (UDCA) 治疗 BILI 的 II 期试验

• 批准号: 7950873
• 负责人: ARUN J SANYAL
• 金额: $ 1.82万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950873
• 关键词: Abdominal Pain; Acute; Alcoholic Pancreatitis; Bile fluid; Biliary; Chronic; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Deoxycholic Acid; Effectiveness; Flare; Frequencies; Funding; Grant; Institution; Lithiasis; Pancreatitis; Patients; Phase; Phase II Clinical Trials; Pilot Projects; Population; Prevalence; Recurrence; Research; Research Personnel; Resources; Source; Testing; United States National Institutes of Health; Ursodeoxycholic Acid; acute pancreatitis; base; chronic pancreatitis; novel

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Alcohol-induced pancreatitis is a chronic and disabling condition characterized by recurrent flares of acute pancreatitis. The pathophysiologic mechanism(s) underlying these recurrent flares are not fully known. In preliminary studies, 55% of subjects with alcohol-induced pancreatitis admitted with a flare of abdominal pain were found to have biliary microlithiasis. Biliary microlithiasis is known to be highly prevalent in those with idiopathic recurrent pancreatitis (1;2). Dissolution of biliary microlithiasis reduces the frequency of acute attacks of pancreatitis in this population. Based on these, the following novel hypothesis is proposed: Biliary microlithiasis is present in a subset of subjects with alcohol-induced pancreatitis and contributes to recurrent flares of acute pancreatitis in such patients. Therefore, its dissolution with urso-deoxycholic acid (UDCA) will reduce the frequency of acute flares of pancreatitis in this population. There are two main objectives of this R21 proposal which are the first steps to testing this hypothesis. These are: 1. TO DEFINE THE PREVALENCE AND TYPES OF BILIARY MICROLITHIASIS IN SUBJECTS WITH ALCOHOL-INDUCED PANCREATITIS Specific Aim 1: To define the point prevalence of various types of biliary microlithiasis in subjects with alcohol-induced pancreatitis. 2. TO PROVIDE 'PROOF OF CONCEPT' THAT UDCA CAN CLEAR THE BILE OF MICRO-LITHIASIS IN SUBJECTS WITH ALCOHOL-INDUCED PANCREATITIS AND IDENTIFY THE FACTORS ASSOCIATED WITH SUCCESSFUL CLEARANCE OF MICROLITHIASIS Specific Aim 2: To perform a PHASE II PILOT study of UDCA (10 mg/kg/day) to define its biologic effectiveness for clearance of biliary microlithiasis in subjects with alcohol-induced pancreatitis and biliary microlithiasis.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 酒精性胰腺炎是一种慢性致残性疾病，其特征是急性胰腺炎的反复发作。这些复发性发作的病理生理机制尚不完全清楚。 在初步研究中，发现55%的酒精性胰腺炎患者因腹痛发作而入院，患有胆道微结石。 已知胆道微结石在特发性复发性胰腺炎患者中非常普遍（1;2）。 胆道微结石的溶解降低了该人群急性胰腺炎发作的频率。 在此基础上，提出了以下新假设： 胆汁微石症存在于酒精诱导的胰腺炎患者中，并导致此类患者急性胰腺炎复发。 因此，其与熊去氧胆酸（UDCA）的溶解将降低该人群中急性胰腺炎发作的频率。 R21建议有两个主要目标，这是检验这一假设的第一步。 这些是： 1. 确定酒精性胰腺炎受试者中胆道微石症的患病率和类型 具体目标1： 明确酒精性胰腺炎患者各种类型胆道微结石的患病率。 2. 提供UDCA可清除酒精诱导胰腺炎受试者中微结石胆汁的“概念证明”，并确定与成功清除微结石相关的因素 具体目标二： 进行UDCA（10 mg/kg/天）的II期初步研究，以确定其在酒精诱导胰腺炎和胆道微结石受试者中清除胆道微结石的生物学有效性。