Gastrointestinal Research and Clinical Trial Center of Georgia is currently conducting clinical trials on the following conditions:

Trial 1:
A study of dietary treatment in Crohn’s Disease. The purpose of the research is to determine if diets or dietary supplements are alternative ways to maintain remission in people with Crohn’s disease. Also, the study is looking to see if dietary treatments change Crohn’s disease related damage to the colon or bacteria in the colon.

Trial 2:
Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial comparing REMICADE® (infliximab) and Placebo in the prevention of recurrence in Crohn's disease patient's undergoing surgical resection who are at an increased risk of recurrence (PREVENT). Prevent is a randomized, multinational, double blind study to assess whether the investigational study medication infliximab (REMICADE®) can prevent the recurrence of Crohn's Disease in patients after surgical resection.

Trial 3:
An investigational study to evaluate the safety and effectiveness of an investigational drug called ustekinumab in people who have moderate to severe Crohn’s Disease and who have been unresponsive to conventional treatments. Ustekinumab is an experimental drug that is being tested in those with Crohn’s disease. The use of ustekinumab in this study is experimental because it has not been approved by the FDA for the treatment of Crohn’s disease. The purpose of this study is to determine whether or not the investigational drug improves symptoms of Crohn’s disease and also to look for any possible side effects of the investigational drug in subjects with Crohn’s disease. This study will compare the benefits and risks of the investigational drug to placebo. Placebo looks like ustekinumab but has no active ingredients.

Trial 4:
An investigational study to Evaluate the Safety and Effectiveness of an investigational drug called ustekinumab in people who have moderate to severe Crohn’s Disease. Ustekinumab is an experimental drug that is being tested in those with Crohn’s disease. The use of ustekinumab in this study is experimental because it has not been approved by the FDA for the treatment of Crohn’s disease. The purpose of this study is to determine whether or not the investigational drug improves symptoms of Crohn’s disease and also to look for any possible side effects of the investigational drug in subjects with Crohn’s disease. This study will compare the benefits and risks of the investigational drug to placebo. Placebo looks like ustekinumab but has no active ingredients.

Trail 5:
A study to investigate a new drug for subjects with moderate to severe Crohn’s Disease. The purpose of this research study is to learn about the effects of the study drug and to find the optimal dose for treating patients ages 18-75 with moderate-to-severe Crohn’s Disease who have failed previous medications.


Bowel Prep

A phase 4, randomized, active comparator, open-label, multicenter study to assess the safety and efficacy of Osmoprep® tablets versus HalfLytely^® and Bisacodyl tablet bowel prep kit for colon cleansing. The primary purpose of this study is to assess safety for Osmoprep^® tablets versus HalfLytely^® and Bisacodyl tablet bowel prep kit in adults who are undergoing colonoscopy.


Diverticulitis

Double-blind, dose-response, randomized, placebo-controlled, parallel group, multi-centre phase III clinical study on the efficacy and tolerability of mesalazine granules vs. placebo for the prevention of recurrence of diverticulitis. The purpose of this study is to find an effective treatment with a high tolerability that prevents the recurrence of diverticulitis. So far, only open-label studies and/or studies without a control group have been performed on this topic. This study will compare the treatment of mesalazine versus placebo granules.


Ulcerative Proctitis

For more information regarding trials contact us.