Clinical Trials

The primary purpose of this study is to create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis (acute pouchitis, CADP, CARP, or CD of the pouch).

The overarching goal of the Study of a Prospective Research Cohort with Inflammatory Bowel Disease (SPARC IBD) is to create a longitudinally followed, well phenotyped cohort of patients with IBD who have linked clinical data, self-reported outcome data, and biosamples that can be used for clinical and translational research that will lead to precision medicine strategies and new therapeutic targets that will improve the quality of life of patients with IBD.

The purpose of this study is to collect blood and stool samples to validate and improve the performance of stool and blood DNA markers for inflammatory bowel disease and colorectal neoplasia critical to the long-term goal of improving effectiveness of neoplasia detection in patients using non-invasive biomarkers to assist colonoscopy and radiographic screening. 

In this study, we will examine the potential side effects experienced after receiving the new hepatitis B vaccine (Heplisav-B) in patients with ulcerative colitis or Crohn's disease. This new vaccine has been found to be more effective than the existing vaccine Engerix in people without ulcerative colitis or Crohn's disease. It is now the standard of practice vaccine that we use in the Mayo gastroenterology and liver practice. The most common side effects include pain, redness, swelling, fatigue, fever and headache. We would also like to determine if there was any worsening of the patient's underlying inflammatory bowel disease.

Part 1

Given these findings and recommendations, members of the Gastroenterology and Infectious Disease department feel that the Heplisav-B vaccine should be the preferred vaccine for patients with IBD and chronic liver disease. In this study, we aim to collect data on patients who receive this vaccine on whether they experience any adverse effects or any worsening of their bowel or liver disease. We also aim to collect data regarding the effectiveness of vaccination by measuring post-vaccination antibody titers at 1 month after vaccination. The goal of this is to confirm that patients have achieved immunity after vaccination. This is consistent with best-practice guidelines and CDC recommendations in immunosuppressed persons.

Part 2:

According to the 2022 Center for CDC guidelines for Hepatitis B vaccination in immunocompromised adults, persons found to have antibody titer concentration <10 mIU/ml (indicating non-immunity) after completion of a primary vaccine series should be revaccinated [6]. Accordingly, in the case of non-immunity after the standard 2-dose Heplisav-B series, we aim to give an additional dose of Heplisav-B and re-measure antibody titers at 1 month in order to evaluate effectiveness. This is consistent with best-practice and CDC guidelines in immunosuppressed patients that have not responded to the primary vaccination series. To this point, the CDC guidelines for Hepatitis B vaccination in immunocompromised adults state that a larger vaccine dose or additional vaccine doses may be necessary in this patient population [6]. Immunity to Hepatitis B through vaccination in patients with inflammatory bowel disease and chronic liver disease is crucial due to high risk of morbidity.

Part 3:

As a continuation of the above, we aim to perform immunological testing to observing T cell response to Heplisav-B vaccination. The goal is to measure if there are any differences in T cell response depending on certain immunosuppressive medications that the patient is taking for their IBD.

The purpose of this study is to identify care needs and research priorities of LGBTQ individuals with IBD using community-based participatory research and human-centered design principles through focus groups.

The purpose of this study is to determine the impact of systemic immunosuppression on sustained antibody COVID-19 concentrations in patients with inflammatory bowel disease (IBD) who received a COVID-19 vaccine.  This observational study will collect blood samples to measure sustained antibody concentrations to evaluate seroprevalence and study immunity  at 6 and 12 months after completion of vaccination.  The primary outcome of this study is to evaluate the immunogenicity of the Covid-19 vaccine in patients with IBD.

The purpose of this study is to compare a limited magnetic resonance enterography (MREN) to routine MREN in order to determine non-inferiority, missed findings, patient tolerance and impact on patient management. 

The objectives of this study are to perform measured testing of the stricture PRO tool, including validation and assessment of responsiveness, and to assess responsiveness of the magnetic resonance image-based stricture radiology index (SRI) items.

The purpose of this study is to collect clinical information, blood and tissue samples from people with Crohn’s disease at the time of their bowel resection and at their standard of care colonoscopy after bowel resection. People without Crohn’s Disease are being asked only to give tissue samples at the time of a clinically indicated colonoscopy so their tissue can be compared to those that have Crohn’s Disease.

This study will compare the genetic codes (DNA) from active disease affected intestinal cells to these same cells from the same patient when they are without disease (inactive). We will be able to conclude which genetic codes are modified in the setting of active and inactive CD. This study has hopes of understanding the root cause of Crohn’s Disease.

The purpose of this study is to demonstrate the impact of an Adult Inflammatory Bowel Disease (IBD) learning health system approach that enables patients and their care teams to coproduce optimal health and high value care.