Digestive Diseases

Below are current clinical trials.

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

1. A Study to Evaluate and Monitor Hepatitis Activity in Hepatitis C Virus Infection Patients Using Advanced Multiparametric MR Elastography (MRE)

   Rochester, Minn.

   The purpose of this study is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for monitoring hepatic inflammation during direct acting antiviral (DAA) treatment, evaluation risks of severe liver injury, and HCC development.

2. A Study to Evaluate Colorectal Polyps with Dietary Inflammation During Colonoscopy

   Jacksonville, Fla.

   Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States (1). Colorectal cancer arises from colonic polyps. The major types of polyps associated with colorectal cancer development are adenomatous (tubular which is most common and other types are villous and tubulovillous) and serrated (hyperplastic, sessile or traditional) polyps with varying degrees of dysplasia (2). Hyperplastic polyps are common but they have a low malignancy potential (3). There is evidence that colonic inflammation plays a major role in colon polyp and colorectal cancer development. For example, inflammatory bowel disease is a major predisposing factor for colorectal cancer occurrence, implicating inflammation in the development of colorectal cancer (4). In addition,  obesity, a chronic inflammatory state, is associated with increased colorectal cancer risk (5). However, the use of anti-inflammatory agents in the prevention of colorectal cancer is controversial, although there is some suggestion that its use may lower colorectal cancer risk (6,7). Diet may affect cytokine levels and inflammation (8). Diet rich in trans-fat and sugar has been shown to increase pro-inflammatory cytokines IL-6 and TNFα (9, 10) and the Mediterranean Diet has been shown to decrease inflammatory cytokines (11) and decrease the risk of colon cancer in an UK study (12). Recently, the EDII was developed and validated to assess inflammatory potential of diet based on the Food Frequency Questionnaire (FFQ) (13).  Here we propose to investigate the association between diet-derived inflammation, as measured by the EDII, risk of colon polyps during screening colonoscopy and colorectal cancer development.

3. A Study of Sonidegib and Pembrolizumab in Advanced Solid Tumors

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

   The purpose of this study is to determine the maximum tolerated dose (MTD) of sonidegib in combination with pembrolizumab in participants with advanced solid tumors as part of the dose escalation phase, and to estimate the response rate of sonidegib in combination with pembrolizumab in participants with NSCLC or pancreas cancer as part of the expansion cohort based on RECIST criteria.

4. A Study to Evaluate Smartphone-based Digital Phenotyping for Relapse Prediction in Alcohol-associated Liver Disease

   Rochester, Minn.

   The primary aim of this study is to define a comprehensive digital phenotype that predicts risk for near-future relapse or relapse in alcohol use in patients with alcohol-associated liver disease.

   The secondary aim of this study is to assess the relationship between this digital phenotype and markers of disease severity outcome, including MELD score and readmission rates.

5. Stem Cell Coated Fistula Plug in Patients With Crohn's RVF

   Rochester, Minn.

   The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with rectovaginal fistulizing Crohn's disease. Autologous means that these cells that coat the plug come from you. You will be in this study for two years. There is potential to continue to monitor your progress with lifelong regular visits as part of your standard of care. All study visits take place at Mayo Clinic and Rochester, MN. The study visit schedule is as follows: Visit 1 (Week -6) - Screening visit: exam under anesthesia and surgery to assess eligibility of fistula tract, take fat biopsy, if eligible, and fecal diversion. Visit 2 (Week 0; Day 0), exam under anesthesia for stem cell coated fistula plug placement Visit 3 (Week 0; Day 1) Visit 4 (Week 2; Month 1) Visit 5 (Week 4; Month 1) Visit 6 (Week 8; Month 2) Visit 7 (Week 12; Month 3) Visit 8 (Week 24; Month 6) Visit 9 (Week 52; Month 12). Visit 10 (Week 104, Month 24)

6. A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

   Rochester, Minn.

   The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

7. Pulmonary Rehabilitation in End-Stage Liver Disease

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The exercise that will be performed in this study will include either pulmonary rehabilitation or a formal home based video strengthening program

8. Suturing Pattern for Endolumenal Stenting Procedures

   Rochester, Minn.

   The purpose of this study is to track endoscopically-placed stents and demonstrate that either suturing pattern is equivalent.

9. Data Collection of PillCamTM SB3 Capsule Endoscopy and Device-Assisted Enteroscopy Routine Care Procedures (GPS Study)

   Scottsdale/Phoenix, Ariz.

   The purpose of this study is to collect PillCamTM SB3 capsule endoscopy (CE) procedures and subsequent device-assisted enteroscopy (DAE) procedures data (double balloon enteroscopy (DBE), single balloon enteroscopy (SBE) and spiral enteroscopy (SE)) in medical centers in the United States (US).

10. A Study to Evaluate the Effectiveness and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

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

    The purpose of this study is to evaluate the effectiveness and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.