Francis A. Farraye, M.D., M.S.

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.

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 assess the prevalence of eating disorders; specifically, Avoidant/Restrictive Food Intake Disorder (ARFID) among adult patients in the IBD clinic and compare to the patient population seen in the primary care clinics at Mayo Clinic Florida.

The primary purpose of this study is to evaluate the effectiveness and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

The purpose of this study is to evaluate the effectiveness of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.

The FMD-ICI study will utilize animal and human data that finds that fasting may promote survival mechanisms and stress resiliency. The study aims to assess the impact that a restrictive calorie diet, mostly of fat and complex carbohydrates, mimicking fasting and increasing resiliency will have in protecting patients from the adverse effects of certain cancer treatments (melanoma, lung, bladder and kidney cancer). By managing the adverse side effects of ICI treatments in select cancer patients, the study will assess the effect of immunotherapy plus the Xentigen fasting mimicking diet on adverse events rates, including immune-mediated colitis. Patients will be supplied with all their dietary requirements for 4 days, through a calorie-restrictive, Xentigen ‘Fasting Mimicking Diet'. The calorie-restrictive/fast-mimicking diet mimicks the effects of fasting on markers associated with stress resistance, reduction of glucose levels and increased levels of ketone bodies. We will also appraise the impact of immunotherapy plus the fasting mimicking diet on physical function nad quality of life as well as evaluate the impact of ummontherapy plus fasting mimicking diet on surrogate markers of inflammation (fecal calprotectin) as a predictive marker of immune-mediated colitis.

The purpose of this study is to assess the effectiveness and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn's disease over a period of 24 weeks and a follow-up period up to 52 weeks.

The purpose of this study is to compare the proteomic markers from gastrointestinal lavage fluid collected from patients with a pancreatic mass to a control group of otherwise healthy subjects.

This will be a prospective study of patients with IBD at Mayo Clinic initially in Jacksonville with possible subsequent extension to other Mayo sites.  We will evaluate the immunogenicity of commercially available COVID-19 vaccines and compare vaccine response among the groups based on their immunosuppressive regimens.  We will divide the immunosuppressive regimens into presumed high vaccine responders Group A and presumed low vaccine responders Group B. We will also assess for adverse reactions to the vaccine and compare with the reported rates in the clinical trials that led to approval of these vaccines.

The purpose of this study is to understand the impact of the COVID pandemic on IBD patients, including infection rates and complications from SARS-COV2, IBD related flares, patient compliance with biologic agents, impact of lockdowns on access to IV infusion centers, need for steroid therapy and admissions for IBD related flares, and modification of medical management.