Gastroenterology and Hepatology

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. In-home Versus In-Clinic Subcutaneous Nivolumab Administration through Connected and Remote Cancer CARE Beyond Walls

   Jacksonville, Fla.

   The purpose of this study is to evaluate the impact of the location of SQ Nivo administration, at the infusion center or in the home, on patient preference and acceptability, safety, patient reported outcomes (PROs), and clinical outcomes.

2. Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers

   Rochester, Minn.

   A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other specified digestive system cancers.

3. Influence of Diet on Tissue and Body Fluids in Health and Disease

   Scottsdale/Phoenix, Ariz.

   This study aims to compare the fatty acid composition of small sample of fat (visceral and subcutaneous) removed at the time of surgery to operative outcomes and the composition calculated from the person’s dietary history and preoperative imaging with MRI/CT scans. This study will also compare the composition of pancreatic fluid collected to that of a sample of fat removed at the time of surgery to drain the collection. Furthermore, we will study the fatty acid composition of drain fluid placed at the time of surgery to that of their fat samples.

4. SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study

   Rochester, Minn.

   The purpose of this interventional study is to test and compare the effectiveness of two elimination diets—the 1-food elimination diet (1FED, milk only) and the 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.

5. A Study to Evaluate the Prevalence and Impact of Eating Disorders Among Patients with Inflammatory Bowel Disease

   Jacksonville, Fla.

   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.

6. A Quality of Life Assessment of Patients with Biliary Obstruction Undergoing Endoscopic or Percutaneous Drainage

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The aim of this study is to compare the quality of life of patients with biliary obstruction who have undergone an endoscopic or percutaneous drainage. The quality of life of patients witll be assessed using the validated "European Quality of Life-5 Dimensions Questionnaire" and the "Intervention-Dependent Questionnaire" which was developed according to current literature as well as the expert opinion of gastroeneterologists.

    

7. A Study to Evaluate Encorafenib Plus Cetuximab with/without Chemotherapy to Treat Metastatic Colorectal Cancer

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of care chemotherapy in participants with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC).

8. The Olmsted NAFLD Epidemiology Study (TONES)

   Rochester, Minn.

   About this study

   Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. It is estimated to affect 1 in 4 adults and it is most commonly found in people who are overweight or obese. Because it is a silent disease (without symptoms until end stage) and the lab tests can be normal, it can be missed in early stages. The fat in the liver can lead to inflammation and eventually scar deposition, which can progress to cirrhosis, liver cancer and need for liver transplantation.

   This study aims to assess how common this disease is in Olmsted County, what markers can identify the disease early to prevent progression to cirrhosis and what other medical problems occur in people with NAFLD in addition to the liver complications. We plan to enroll a large number of adults, assess their liver with state-of-the-art tests available at Mayo Clinic and follow them over several years to monitor for disease progression and other health complications. The ultimate goal of the study is to identify new markers that predict presence of fatty liver and poor health outcomes, in order to improve population health in the community.

   Participation eligibility

   Participants will be identified from the Olmsted County population age 18 or older.

   Inclusion criteria:

   1.         Adults age 18 years or older

   2.         Olmsted County residents at the time of study entry

    

   Exclusion criteria:

   1.         Pediatric population (age<18)

   2.         Unwilling to participate or unable to consent

   3.         Known liver disease other than NAFLD at the time of survey

   4.         Pregnant women

   5.         Alcohol use in excess (14 drinks or more per week for women and 21 drinks or more per week for men)

9. Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

   Scottsdale/Phoenix, Ariz.

   This study is being done to better understand the relationship between inflammation in your AT, abnormal deposition of fat around your liver and how this affects its appearance and function and ultimately insulin resistance.

10. A Study to Evaluate Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis

    Rochester, Minn.

    Ulcerative Colitis (UC) is a chronic inflammatory disease affecting the mucosal lining of the colon and rectum and the incidence is increasing, but the etiology remains unknown. Patients may require a proctocolectomy due to refractory disease. Prior to an operation, UC is treated with antibiotic therapy, immunomodulatory therapy and immunosuppressive agents. While there is an increasing number of approved biologics for the treatment of UC, there are many patients that still suffer from refractory disease. Thus, alternative mechanisms of therapy are desperately needed.

    Treatments that have the potential to reduce mucosal inflammation could alleviate the pathology of luminal UC. This trial will use arterially delivered mesenchymal stem cells (MSCs) to produce these regenerative signals allowing for mucosal healing. This study will enroll patients with medically refractory moderate to severe inflammatory UC who are or plan to be scheduled for a colectomy. Patients enrolled will be those who failed all attempts at standard treatment including antibiotics, corticosteroids, immunomodulator, and/or biologic therapy.

    Participants will undergo screening for study, if eligible, participants will be dosed with 15 million or 30 million cells will be administered via IA delivery with interventional radiology. Participant study visits after study intervention includes visits on: Day 1, Week 1, Week 2, Week 8, Week 24, Week 52, and Week 104.