Inflammatory Bowel Disease Research Studies
Baylor College of Medicine is an official member of the Crohn’s and Colitis Foundation of America’s Clinical Research Alliance. This allows our site to be involved in multi-centered studies that are headed by the CCFA.
We are currently conducting several studies that can be grouped under the following major headings:
Drug Registry
We are conducting registry studies to monitor those patients who are taking biologic medications:
- CD INFORM - This is an observational study designed to obtain long-term safety data on patients with Crohn’s Disease being treated with Tysabri (natalizumab). The study duration is five years and subjects will be followed during normal physician visits.
- SECURE - This is an observational study designed to track safety outcomes of patients who have taken Cimzia (certolizumab) for the treatment of Crohn’s disease compared to a non-Cimzia control population. The study duration is 10 years and subjects will be followed during normal physician visits and through web surveys and telephone calls.
Treatment Studies
We are also conducting several studies that offer new medications which may improve your disease if conventional medications have failed in the treatment of your ulcerative colitis or Crohn’s disease. These include:
- CERTIFI – This study evaluates the safety and efficacy of Ustekinumab therapy in adult subjects with moderate to severe Crohn’s disease who have received TNFα antagonists Remicade (infliximab), Humira (adalimumab) or Cimzia (certolizumab pegol) and either did not respond initially, responded initially but then lost response or where intolerant to the medication. The study duration is 36 weeks.
- MILLENNIUM – This study evaluates the safety and efficacy of MLN0002 in subjects with either moderate to severe Crohn’s disease or moderate to severe Ulcerative Colitis who have failed previous therapy with either TNFα antagonists Remicade (infliximab), Humira (adalimumab) or Cimzia (certolizumab pegol) or Immunomodulators. This could be due to an inadequate response, loss of response or intolerance to the medication. The study duration is 52 weeks, however, there is the option to continue in a long-term, open-label study for an additional two years.
Other studies
- PIANO- Pregnancy and IBD: This study evaluates the impact of IBD and the use of medications to treat the disease has on the mother and baby up to 1 year of age. This study involves the completion of questionnaires at each trimester, after delivery, and at one year after delivery.
- Role of race and ethnicity in IBD – This study evaluates whether genetic markers and/or immune response patterns can be identified and associated with the racial/ethnic distribution of IBD. This study involves a one time blood draw and the completion of a single questionnaire.
- Impact of diet and nutrition on IBD – This study is evaluating what impact diet and nutrition has on IBD including whether certain dietary habits can cause IBD, what nutritional deficiencies are seen in patients with IBD and whether dietary modifications can alter the symptoms/course of the disease. The study involves the completion of a single questionnaire.
- Transitional survey - This study evaluates the different aspects of pediatric to adolescent adult transition in IBD patients, including medication use, impact that the disease has on your life, and your comfort level in transitioning to an adult gastroenterologist. The study involves the completion of a single questionnaire.
For more information on Inflammatory Bowel Disease-related studies at BCM:
Please contact our research coordinator, Sara Raymon at 713-798-7616.