Open label, randomized, crossover clinical trial to evaluate the efficacy of increasing doses of pancreatic enzymes against inhibition of acid gastric secretion in patients with exocrine pancreatic insufficiency secondary to chronic pancreatitis

Department of gastroenterology. University Hospital of Santiago0 个研究点开始时间: 2016年4月18日最近更新: 2016年4月25日

试验速览

暂无简介。

•1. Chronic Pancreatitis diagnosed by CT scan, endoscopy ultrasound (EUS) or MRI
•2. Pancreatic exocrine insufficiency diagnosed at inclusion by the 13C-MTG breath test and defined as a 13C-CCR <29%.
•3. Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Age < 18 years
•2. Pregnancy or lactancy.
•3. Unwillingness or inability to understand the study and sign the consent, or to accomplish with the visits and procedures of the study.
•4. Any kind of uncured malignant disease.
•5. Need of any therapy known to influence pancreatic secretion (e.g. somatostatin and somatostatin analogs).
•6. Impossibility to stop the treatment with gastric acid inhibitors
•7. Any disease associated with a severe gastrointestinal dysmotility (e.g. long lasting diabetes mellitus, sclerodermia).
•8. Any kind of gastrointestinal or pancreatic surgery except appendicectomy or cholecistectomy
•9. Any experimental drug consumption in the four weeks prior to study entry
•10. Any kind of liver disease, celiac disease, inflammatory bowel disease or any other concomitant disease potentially affecting digestion or intestinal absorption.
•11. Any kind of severe restrictive lung disease which could potentially alter the result of the pancreatic function breath test.

发起方

Department of gastroenterology. University Hospital of Santiago