drugset / Trial / NCT00858858
Clinical Studies on Bile Acids in Barrett's Esophagus
Non-randomizedSingle-groupOpen-labelBasic science
Summary
This study has two major goals: 1. To determine the effects of bile salts on causing DNA injury and activating signaling pathways that promote growth in cells from the esophagus of patients who have gastroesophageal reflux disease (GERD) 2. To determine whether changes in bile composition induced by treating patients with a bile salt called ursodeoxycholic acid (UDCA) can alter DNA injury, signaling pathway activation and other types of damage in cells from the esophagus of patients who have GERD.
Timeline
- Start
- 2009-03
- Primary completion
- 2013-03
- Completion
- 2015-02
Publications
- Background Huo X, Juergens S, Zhang X, Rezaei D, Yu C, Strauch ED, Wang JY, Cheng E, Meyer F, Wang DH, Zhang Q, Spechler SJ, Souza RF. Deoxycholic acid causes DNA damage while inducing apoptotic resistance through NF-kappaB activation in benign Barrett's epithelial cells. Am J Physiol Gastrointest Liver Physiol. 2011 Aug;301(2):G278-86. doi: 10.1152/ajpgi.00092.2011. Epub 2011 Jun 2.
- Peng S, Huo X, Rezaei D, Zhang Q, Zhang X, Yu C, Asanuma K, Cheng E, Pham TH, Wang DH, Chen M, Souza RF, Spechler SJ. In Barrett's esophagus patients and Barrett's cell lines, ursodeoxycholic acid increases antioxidant expression and prevents DNA damage by bile acids. Am J Physiol Gastrointest Liver Physiol. 2014 Jul 15;307(2):G129-39. doi: 10.1152/ajpgi.00085.2014. Epub 2014 May 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ursodeoxycholic Acid | Small molecule | 10 mg/kg | Oral |