Clinical Research For
By volunteering to participate, you may be able to make important contributions to scientific research. Each clinical trial is different, but the information provided below can help you consider whether a clinical trial may be right for you.
When you are considering participation in a clinical trial, it is important to understand what will be expected of you before, during, and after the trial. Visit the "What to Expect" page on this website for general information.
For clinical trials of Crohn’s Disease and Ulcerative Colitis, you will probably need to visit the research doctor more often than you do for your normal care. These frequent visits may go on for a year or more. During the clinical trial, you will have several types of assessments, such as stool samples, patient-reported outcomes, and colonoscopy. Please note that the procedures for a specific study may differ from this list, so be sure to follow the instructions provided by your research doctor.
Stool samples, along with other lab values such as blood draws and urine samples, are collected and analyzed at several time points throughout the clinical trial.
For studies of Crohn’s Disease and Ulcerative Colitis, stool samples may be analyzed to be sure you don’t have an infection (such as C. difficile) or to test for a potential biomarker of your disease (such as fecal calprotectin).
Stool samples may be collected at the research center, or you may need to collect the stool samples at home and return them for analysis, either by mailing the sample or dropping it off at the research study center. Instructions will be provided with the kit from the research center. Follow these instructions carefully, as some stool samples will need to be kept cold or returned within a short period of time, to be sure the testing can be completed accurately.
Patient-Reported Outcomes provide important information from the patient’s perspective.
During clinical trials for Crohn’s Disease and Ulcerative Colitis, we use patient-reported outcomes to better understand your symptoms (including stool frequency, fatigue and abdominal pain), the emotional and mental impact of your disease, and the impact of your disease on your daily activities.
Usually, a series of questionnaires will be given to you at the research study center during regularly scheduled visits. You may also be given a study diary or electronic device to track your symptoms and flares at home, between visits to the research center. You will need to bring the study diary or electronic device with you to all your research visits.
Colonoscopy is a procedure that allows the research center staff to examine the entire colon.
In clinical trials for Crohn’s Disease and Ulcerative Colitis, a colonoscopy is used to assess the effectiveness and safety of the study medication and to manage your care. During the colonoscopy, research center staff may take tissue samples (biopsy) of your colon for research purposes.
You may need to have more than one colonoscopy or biopsy during the clinical trial. The research center staff will tell you how to prepare for the colonoscopy. Follow the preparation steps carefully in the days before your scheduled procedure.
Preparation is key
Know your body