SCHOOL OF MEDICINE

Department of Medicine

IU Inflammatory Bowel Disease

Clinical Trials

 

Contact any of the below listed coordinators if interested in any of these studies:

Name

Phone

E-mail

Debbie Drenzyk, Clinical Research Nurse

317-948-9212

robinsd@iu.edu

Tonika Peterson, Clinical Study Technician

317-948-3369

tonipete@iu.edu

Emmalee Phelps, Clinical Study Technician

317-278-9232

phelpse@iu.edu

 

We are currently enrolling for the following studies:

Study

Patient Population

PI

Oral GED-0301 (Mongersen)  for the treatment of active Crohn’s disease (2 studies with a long-term extension study) NCT02596893

Adult patients with active Crohn’s disease without prior use of biologics (002) and patients with or without prior use of biologics (004).

Monika Fischer, MD

MED12070, an IL-23 monoclonal antibody, for moderate to severe Crohn’s disease NCT02574637

Adult patients with active Crohn’s disease who have failed or are intolerant to Anti-TNF Therapy (ex: Adalimumab, Infliximab, Vedolizumab, Ustekinumab, etc)

Monika Fischer, MD

Oral GS-6034 (Filgotinib) for moderate to severe Crohn’s disease (3 studies based on location of disease in colon and one long-term extension study) NCT02914561

Adult patients with active Crohn’s disease, small bowel Crohn’s disease, or fistulizing Crohn’s disease

Matthew Bohm, DO

Oral RPC1063 for moderate to severe Ulcerative Colitis NCT02435992

Adult patients with active Ulcerative Colitis

Matthew Bohm, DO

Oral Lactoferrin (purified from milk) for anemia in Crohn’s disease

Adult patients with active Crohn’s. Patients must have anemia and have not been taking IV iron in the last 3 months

Sashidhar Sagi, MD

Addition of an Immunomodulator (Methotrexate or Azathioprine) to aid in Adalimumab or Infliximab patients with either Crohn’s disease or Ulcerative Colitis NCT02413047

Adult patients with Crohn’s or Ulcerative Colitis currently taking Adalimumab or Infliximab who have lost response to the drug

Matthew Bohm, DO

Fecal Microbiota Transplant (FMT) for the treatment of recurrent C. Difficile infection

Adult patients with at least 3 documented episodes of C. Difficile not responding to Metronidazole (Flagyl), and/or Vancomycin, and Dificid (Fidaxomicin)

Monika Fischer, MD

LY3074828, an IgG monoclonal antibody, for active Crohn's Disease NCT02891226 Adult patients with active Crohn's disease who have had prior Crohn's treatment (5ASA, 6MP, AZA, steroids, or biologics without exposure to Ustekinumab) Monika Fischer, MD
Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to induce remission in Crohn's Disease NCT03058679 Adult patients with Crohn's disease who do not have any allergy to nuts or have diabetes that require medication. Monika Fischer, MD
Inflammatory Bowel Disease and Recurrent Clostridium difficile infection: outcomes after Fecal Microbiota Transplantation NCT03106844 Adult patients with Crohn's disease or ulcerative colitis who have had at least 2 episodes of clostridium difficile infection with vancomycin failure. Patients will undergo Fecal Microbiota Transplantation through colonoscopy.

Monika Fischer, MD

Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus decolonization NCT03063437 Adult patients with positive VRE infection within the last 7 day, with the ability to swallow capsules, and who are not currently on any antibiotics. Monika Fischer, MD