Gastroenterology and Hepatology

Below are current clinical trials.

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

1. Futibatinib and Pembrolizumab for the Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

   Rochester, Minn.

   This is a single-arm, two-stage, phase II trial to assess the efficacy of futibatinib plus pembrolizumab in advanced hepatocellular carcinoma for patients with FGF19 expression. Patients will receive futibatinib 20mg daily Days 1-21 and will receive pembrolizumab 200mg Day 1 of each 21 day cycle per current clinical standard of care. Patient will receive treatment until disease progression or unacceptable toxicities. Patients will undergo restaging scans every 3 cycles. Subjects will be monitored for adverse events from the beginning of the study drug to 28 days after the last dose. We will collect blood samples for determination of cell free DNA and circulating tumor cells at baseline, after 3 and 6 cycles, and at progression. We will collect tumor biopsy specimens before treatment initiation to develop patient derived tumor organoid.

2. Celiac Disease Registry

   Rochester, Minn.

   The purpose of this study is to develop a resource (bank) of biospecimens (blood, tissue, stool) and data collected from individuals with known or suspected gluten enteropathy, including celiac disease (CD) and dermatitis herpetiformis (DH).  Other enteropathies will also be included: collagenous sprue, idiopathic sprue, lymphocytic enterocolitis, idiopathic enteropathies, collagenous gastritis, Whipple’s disease, and other miscellaneous inflammatory disorders of the small intestine. This resource will be invaluable in answering the important questions outlined above and other future unanswered questions.   

3. A Study to Evaluate the Response of Dietary Therapy in Eosinophilic Esophagitis (EoE)

   Rochester, Minn.

   The purpose of this study is to investigate the response rate of dietary therapy in patients with Eosinophilic Esophagitis (EoE) and determine rates of long-term compliance with the food elimination diets (SFED, FFED, step-up), and also to identify patient, clinical, and endoscopic factors that may be associated with increased rates of success in patients undergoing dietary therapy in EoE.

4. Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic Celiac Disease Patients

   Rochester, Minn.

   This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a gluten free diet (GFD) for at least one year prior to screening.

5. Improving the Quality of Care for Adults with Inflammatory Bowel Disease

   Jacksonville, Fla.

   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.

6. A Study to Detect Pancreatic Cancer Using Circulating Tumor Markers

   Rochester, Minn.

   The primary purpose of this study is to select and validate candidate methylated DNA markers (MDMs) (individually and in combined panels) for the detection of pancreative ductal adenocarcinoma (PDAC). The potential complementary value of mutant KRAS and CA19-9 will also be evaluated.

7. A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.

8. Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus

   Rochester, Minn.

   The purpose of this multicenter, prospective, single arm, non-randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.

9. A Study to Evaluate the Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

   Rochester, Minn.

   The purpose of this study is to understand why patients with indigestion, with or without diabetes, have gastrointestinal symptoms and, in particular, to understand where the symptoms are related to increased sensitivity to nutrients.Subsequently, look at the effects of Ondansetron on these patients' symptoms.

10. A Study to Establish an Obesity-Related Phenotype Registry

    Rochester, Minn.

    The purpose of this study is to create a registry of obese patients who have been phenotyped to understand the heterogeneity of obesity.