The Digestive Diseases Institute has an active research program.

The basic research has included:

Cytokine levels in inflammatory bowel disease Cytokine and other anti-inflammatory levels in acute pancreatitis Experimental research on the translocation of bacteria through the gut in patients with pancreatitis especially alcoholic pancreatitis

The clinical research has included: detailed studies on the long-term prognosis and severity parameters in acute pancreatitis, many aspects of chronic pancreatitis and very significantly the effect of local anesthesia on the ampulla of Vater on the ease of cannulation at ERCP and the prevention of post-ERCP pancreatitis. In addition, a study was completed with an anti-inflammatory cytokine in acute pancreatitis; i.e., platelet activating antibody factor which proved not to be effective.

Many long-term studies on the effect of proton-pump-inhibitors in the long-term treatment of gastroesophageal reflux and a multi-center Long Island study on the effect of proton-pump inhibitors on preventing cancer and dysplasia in Barrett's esophagus. Currently, the division is doing trials on various interferons in Hepatitis C and Hepatitis B and the effect of fatty liver on inflammatory hepatic disease and its prevention.

GI Clinical Trials

We are actively enrolling in the following trials:

Treatment of Hepatitis C
Protocol VX03-4970205 — A Phase 2b Study of Merimepodib in Combination with Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin in Subjects with Chronic Genotype 1 Hepatitis C Non-Responxive to Prior Therapy with Pegylated Interferon Alfa and Ribavirin — Treatment for Hepatitis C.

Schering-Plough — PO3471 — Comparison of PEG-Intron 1.5 ug/kg/wk Plus Rebetol vs PEG-Intron 1 ur/kg/wk Plus Rebetol vs. Pegasys 180 ug/wk Plug Copegus in Previously Untreated Adult Subjects with Chronic Hepatitis C Infected with Genotype 1. Treatment of Hepatitis C

Treatment of Hepatitis B
GS-US-174-0102 and GS-US174-0103 — A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF vs. Adefovir Dipivoxil for the treatment of Presumed Pre-Core Mutant Chronic Hepatitis B. Treatment for Hepatitis B

Treatment for Dyspepsia
Novartis - CHTGF919D2302 — A six-week randomized double-blind placebo-controlled multicenter study to assess the efficacy and safety of oral Tegaserod (6mg bid) and placebo in female patients with Dyspepsia. Treatment for Dyspepsia.

Advanced Hepatocellular Carcinoma
Bayer - Protocol 100554 — A Phase III Randomized Placebo-Controlled Study of Sorafenib in Patients with Advanced Hepatocellular Carcinoma.

LOOK OUT FOR OUR FUTURE TRIALS:

Intravenous Steroid-Refractory Ulcerative Colitis
PDL — Protocol 291-415 — A Phase II, Randomization, Double-Blind, Multicenter, Dose-exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis Visilizumab (Nuvion)

Treatment of Hepatitis C
GSK — Protocol VX05-950-104 — A Phase 2 Study of 2 Dose Regimens VX-950 in Combination with peginterferon alfa-2a (Pegasys) with & without ribavirin (Copegus) in Subjects with Hepatitis C. Treatment of Hepatitis C

Diarrhea
Salix — Protocol RFCL3001 — A Double-Blind, Randomized, Controlled Trial of Rifazimin Comparied to Vancomycin for the Treatment of Clostridium Difficile-Associat4ed Diarrhea (CDAD)

Gastroparesis
Parexcel — A 12-Week Randomized Parallel-Group Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of a new motilin receptor agoinst in Subjects with Symptomatic Diabetic Gastroparesis. Treatment of Gastroparesis.

Crohn’s Disease
A Phase IIIb multicenter, open lable induction and double blind comparison of two maintenance schedules evaluatino clinical benefit and tolerabilityof subcutaneous studydrug, a pegylated Fab fragment of humanized antibody to tumor necrosis factor (TNF) over 26 weeks in patients suffering from Crohn's Disease with prior loss of response of intolerance to infliximab. Treatment of Crohn's Disease.