Dr. Stephen Hanauer is a world leader in the treatment of inflammatory bowel diseases (IBD).

He is the past chair of the Immunology, Microbiology and Inflammatory Bowel Disease Section of the American Gastroenterological Association (AGA). Dr. Hanauer is also a recipient of the AGA's Fiterman Award for Clinical Research and the AGA's Janssen Award for Clinical Excellence. Additionally, he has been named one of America's Top Doctors by Castle Connolly Medical Ltd.

Dr. Hanauer previously served as a member and chair of the Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee. He currently serves as chair of the International Organization for Inflammatory Bowel Disease, secretary-elect of the American College of Gastroenterology, and a member of the GI Specialty Board of Internal Medicine.

Northwestern University Feinberg School of Medicine

The Division of Gastroenterology provides outpatient treatment of digestive disorders and gastrointestinal diseases. A diverse medical staff has expertise in diagnosing and treating the full range of GI diseases, including cancers of the digestive system, Crohn's disease, inflammatory bowel disease, ulcerative colitis, peptic ulcer disease, esophageal diseases, gallstones and their complications, and pancreatic diseases. Division members are active in research into GI motility and manometry, absorption-nutrition, gastrointestinal immunology, gastrointestinal cancer, and interventional endoscopy.

 Outcome after surveillance of low-grade and indefinite dysplasia in patients with ulcerative colitis.

 Two brothers with skewed thiopurine metabolism in ulcerative colitis treated successfully with allopurinol and mercaptopurine dose reduction.

 Safety and effectiveness of long-term allopurinol-thiopurine maintenance treatment in inflammatory bowel disease.

 Long-term Treatment of Patients With a History of Ulcerative Colitis Who Develop Gastritis and Pan-Enteritis After Colectomy.

 Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Ages Eligible for Study: 18 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

 Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC. The cause of UC is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease. It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.

Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

 Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (Merit-UC)

There are fewer therapeutic options for patients with active ulcerative colitis (UC) compared to patients with active Crohn's disease (CD) and the investigators are facing a persistent unmet need for additional effective and affordable therapies for patients with UC. Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly (im) is an efficient therapy to induce and maintain steroid free remission in patients with CD. To evaluate the efficacy of a similar approach in patients with active ulcerative colitis the investigators conduct a double-blind, placebo controlled, randomized, multicenter, parallel group trial to investigate the safety and efficacy of 25 mg MTX applied subcutaneously once weekly in patients with active UC, who either failed 5-ASA therapy, or are steroid dependent or are intolerant or not responding to azathioprine/6-mercaptopurine therapy or have no response/ lost response to infliximab prior to the study inclusion. The study is designed as a drug withdrawal trial and includes two periods, the Induction Period (week 0-16) and the Maintenance Period (week 17-48). In the open label Induction Period every patient will receive a steroid taper, MTX 25 mg sq once weekly + daily folic acid 1 mg tablets for the induction of clinical response or remission. Patients responding to the open label MTX therapy and being off steroids between week 12-16 will be randomized at week 16 1:1 to Placebo sq once weekly + daily folic acid 1 mg tablets + 2.4 g mesalamine or to MTX 25 mg sq once weekly + daily folic acid 1 mg tablets+ 2.4 g mesalamine. The Specific Aims of the trial are: i) To evaluate the safety and tolerability of 25 mg MTX applied sq once weekly over a time period of 48 weeks; ii) To evaluate the relapse-free survival of MTX maintenance therapy compared to placebo over a time period of 32 weeks; iii) To evaluate the efficacy of MTX over a time period of 16 weeks to induce steroid free remission; iiii) To establish a DNA, plasma and serum library to enable the evaluation of clinical and pharmacogenomic models to predict the response to MTX therapy in patients with UC. With 25-30 participating centers actively enrolling, the investigators anticipate to complete enrollment for this study in a time period of 3 years. Completion of this trial will define the therapeutic value of MTX in UC, potentially changing the current therapeutic strategy in UC.

Estimated Enrollment: 220
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)