Gastroenterology Fellowship
Active Research
| Divison | Study Area | Principal Investigator (PI) | Contact Infromation | Study Name and Type | Study Description | Main Incusion Criteria | Recruiting | Open |
|---|---|---|---|---|---|---|---|---|
| Celiac Disease | Celiac | Divya Ashat, MD diva-ashat@uiowa.edu | Megan Sharer, RN, BSN, MBA (319) 467-4769 megan-sharer@uiowa.edu | DONQ52, humanized monoclonal modified Ig G1 antibody | A Phase 11B, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safely of DONQ52 in active celiac disease patients who have duodenal mucosal damage and persistent symptoms despite attemping a gluten-free diet (daisy study) | Celiac disease with positive serology and intestinal histology with HLA-DQ2.5 genotype | Yes | Yes |
| Inflammatory Bowel | Crohn's Disease | Steven Polyak, MD steven-polyak@uiowa.edu | Megan Sharer, RN, BSN, MBA (319) 467-4769 megan-sharer@uiowa.edu | Takeda TAK-279-CD - oral TYK2 | TAK-279-CD-2001: A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn's Disease | Moderate to severe CD, history of inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD | Yes | Yes |
| Inflammatory Bowel | Crohn's Disease | Steven Polyak, MD steven-polyak@uiowa.edu | Megan Sharer, RN, BSN, MBA (319) 467-4769 megan-sharer@uiowa.edu | TRX Bio: TRX103-02 Cell Therapy Infusion | TRX Bio: A phase 1/2a, Open Label, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX103 in Subjects with Merate to Severe Treatment-Refractory Crohn's Disease | Moderate to severe CD, history of inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD | Yes | Yes |
| Inflammatory Bowel | Crohn's Disease | Divya Ashat, MD diva-ashat@uiowa.edu | Megan Sharer, RN, BSN, MBA (319) 467-4769 megan-sharer@uiowa.edu | VOICE/TAK01796; Observational Study in patients with Crohn's Disease and Vedolizumab | Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants with Crohn's Disease Using Patient-Reported Outcome Measures (VOICE): A Prospective Obervational Study | Patient with confirmed CD and prescribed Vedolizumab | Yes | Yes |
| Inflammatory Bowel | Steven Polyak, MD steven-polyak@uiowa.edu | Dr. Polyak is open to defining and starting up any clinical IBD research project if there are interested residents or students. This requires more time when starting up. | ||||||
| Liver | Alpha 1 Antitrypsin Deficiency | Tomohiro Tanaka, MD tomohiro-tanaka@uiowa.edu | Julie Szewc, RN, BSN (319) 467-4923 julie-szewc@uiowa.edu | Takeda TAK-999-3001 ~SC Injextion RNAi therapeutic | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Faziesiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F$ Fibrosis | Alpha-1 Antitrypsin Deficiency, PiZZ | Yes | Yes |
| Liver | Bio89 MASH | Antonio Sanchez, MD antonio-sanchez@uiowa.edu | Julie Szewc, RN, BSN (319) 467-4923 julie-szewc@uiowa.edu | Bio89-100-131 and Bio90-100-132 | 131: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfuction-Associated Steatohepatitis (MASH) and Fibrosis 132: A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) | F2-F3 or F4 | Yes | Yes |
| Liver | PBC | Alan Gunderson, MD alan-gunderson@uiowa.edu | Julie Szewc, RN, BSN (319) 467-4923 julie-szewc@uiowa.edu | CB8025-41837- oral capsule, seladelpar - peroxisome proliferator-activated receptor delta | AFFIRM: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Effect of Seladelpar on Clincial Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis | PBC and compensated cirrhosis | Yes | Yes |
| Liver | PBC | Antonio Sanchez, MD antonio-sanchez@uiowa.edu | Jena Neuhaus, RN, BSN (319) 335-0123 jena-neuhaus@uiowa.edu | Mirum PBC Clinical Trial – Oral Volixibat | Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE) | PBC | Yes | Yes |
| Liver | NAFLD | Frederick Johlin, MD frederick-johlin@uiowa.edu | Megan Sharer, RN, BSN, MBA (319) 467-4769 megan-sharer@uiowa.edu | NAFLD Treatment with SIRT1 Oral Therapy | Investigation of the Effect of Antioxidant Therapy and SIRT1 Stimulation in Patients with Non-Alcoholic Fatty Liver Disease from Metabolic Syndrome | NAFLD, F2 or F3 | Yes | Yes |
| Motility | Eosinophilic Esophagitis (EoE) | Rami El Abiad, MD rami-elabiad@uiowa.edu | Ethan Hoover, RN (319) 335-9767 ethan-hoover@uiowa.edu | AstraZeneca (Tezepelumab) – SC mAb IgG2λ | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING) | Biopsy proven EoE, experiencing dysphagia symptoms | Yes | Yes |
| Motility | Eosinophilic Esophagitis (EoE) | Rami El Abiad, MD rami-elabiad@uiowa.edu | Ethan Hoover, RN (319) 335-9767 ethan-hoover@uiowa.edu | Uniquity One - SC Ig G1monoclonal antibody that binds to human TSLP | A Phase 2, Randomized, Double-Blind, Multicenter Placebo-Controlled Study with an Open-Label Extension to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinphilic Esophagitis (ALAMERE) | Biopsy proven EoE, experiencing dysphagia symptoms | Yes | Yes |
| Parenteral Nutrition | Parenteral Nutrition | Caryn Berkowitz, MD caryn-berkowitz@uiowa.edu | Megan Sharer, RN, BSN, MBA (319) 467-4769 megan-sharer@uiowa.edu | Safety and Efficacy of Defencath in Reducing CLABSIS | A Phase 3, prospective, multicenter, double-blind, randomized, controlled, adaptive study to demonstrate the safety and efficacy of defencath in reducing central line-associated bloodstream infections (clabsis) in adult participants receiving total parenteral nutrition (TPN) via central venous catheter (CVC) | Patients who have a permanent tunneled CVC or PICC and require long-term TPN | Yes | Yes |