Clinical Research For Crohn's Disease

+ Ulcerative Colitis

New treatments for Crohn’s Disease and Ulcerative Colitis cannot be developed without clinical trial volunteers. 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.

What happens in a clinical trial for Crohn’s or Ulcerative Colitis?

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.

Why we need them:

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).

How we collect them:

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.

Why we need them:

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.

How we collect them:

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.

Why we need them:

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.

How we collect them:

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.

Colonoscopy preparation tips:

  • Preparation is key

    • Good preparation for the colonoscopy procedure is critical to the success of the trial and avoid repeating the colonoscopy.
    • Discuss your preparation procedure with the research center staff. You may be able to make adjustments to the preparation medications, depending on your specific needs. Let the research center staff know if you are having trouble or difficulty during the prep.

  • Know your body

    • Consider taking time off before and after the colonoscopy, if the prep is draining for you or you need time to recover.
    • Once the procedure is done, slowly re-introduce food and re-establish your bowel routine as your body recovers.

  • Stay organized

    • Ask the research center staff if you need to bring any clinical trial materials with you on the day of the colonoscopy.
    • Bring a notebook or folder to take notes or store your follow-up instructions.

  • Have support

    • On the day of the colonoscopy, bring a partner with you whom you trust.
    • Your trusted partner will need to discuss preliminary results with your clinical trial doctor and take notes for you as well as drive you home safely for recovery.

  • Other tips

    • During preparation and the day of the procedure, wear loose clothing that is easy to put on and take off.
    • During preparation, consider using an adult diaper or pad, just in case of accidents while the bowel is emptying.

Clinical Trials for Crohn’s and Ulcerative Colitis

Resources

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Informed Consent: A Process Designed For You

Learn about informed consent—the process designed just for you to learn about a clinical trial and your role in a study before making a decision to participate.

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Participating in a Clinical Trial: What to Expect

Are you wondering what to expect from a clinical trial experience? Learn about the entire life cycle of the clinical trial journey.

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Patient-Focused Drug Development: A Systematic Approach

HCPs may be experts on clinical aspects of a given medical condition, but patients are experts on what it’s like to live with it. This is why Patient-Focused Drug Development is so valuable.

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Lab Samples and Clinical Research

Lab samples provide some of the most important knowledge we gain in clinical research. Learn when, where and why samples are collected during a trial.

Other Resources for Crohn's Disease and Ulcerative Colitis

-Crohn's and Colitis Foundation -American College of Gastroenterology -Mayo Clinic -Inspire

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