Below is a list of our IBD clinical trials that are currently enrolling patients:

• Dietary Treatment of Crohn's Disease  (Chicago and Macon, Georgia)
• Mind/Body Medicine and Inflammatory Bowel (IBD) Flare-Up (Chicago only)
• Dysbiosis and IBD (Chicago only)
• Crohn's Disease and Ustekinumab Therapy (Chicago only)

For more information about any of these studies, please call the GI Clinical Trials Office at Rush at (312) 942-3466.

Dietary Treatment of Crohn's Disease

Principle Investigator: Ece Mutlu, MD, MS, MBA

Eligibility Criteria: You may be eligible for this study if you:

• Have documented Crohn's
• Have received the same dose of Crohn's medications for the last 12 weeks

Study Description

This research is a randomized, double-blind, placebo-controlled, clinical trial studying the effects of diet or dietary supplement in maintaining remission of Crohn's disease (CD). The main purpose is to find out whether such diets or supplements are safe, acceptable and beneficial. The study is also looking to see if dietary treatments change Crohn's-disease-related damage in the colon (i.e. oxidative stress) or the bacteria in the colon.

Each person participating in the study will need to follow a study diet and take a study supplement. A total of 13 visits over the course of 54-weeks will occur. The end of the study is at 54 weeks or sooner if Crohn's disease flares up. Persons in the study will need to record symptoms, bowel habits, supplement ingestion, and the foods they eat in a diary. They will also fill out questionnaires on disease activity and how it impacts life (i.e. quality of life). They will have blood drawn at each visit. They will be asked to collect four stool samples. They will need to undergo sigmoidoscopy with biopsies (or possibly a colonoscopy) at the beginning and at the end of the study.

Persons in the study will be asked to change their diet, which may cause their grocery bill to change, may cause incompatibility with a "fast food"/"dining out" lifestyle, and may increase time allocated to shopping and cooking. This study cannot reimburse for any costs associated with the dietary changes, but will provide free access to support and guidance with these changes.

Participants enrolled in the study will receive the following free of charge:

• Physician visits
• Dietitian visits
• Parking/transportation
• Dietary supplements
• Procedures and blood work that are not part of usual and customary medical care will also be paid for by the study.

We hope that the results will help us understand Crohn's disease better, benefits other patients with Crohn's disease in the future, and help us to develop alternative non-medication or surgical strategies for maintaining Crohn's disease in remission.

Compensation: Participants will also receive $200 for successful completion of the study.

Mind/Body Medicine and Inflammatory Bowel Disease (IBD) Flare-Up

Principle Investigator: Ali Keshavarzian, MD

Eligibility Criteria: In order to participate you must:

• Have moderately severe ulcerative colitis in remission (flare-up in the past 6 months)
• Have no history of colon resection
• Not be pregnant

Study Description

The purpose of this study is to determine whether practice of one of two 8-week mind/body courses, among patients with moderately severe ulcerative colitis in remission, prevents flare-up of the disease.

Compensation: Participants will receive $300 for successful completion of the study.

Dysbiosis and IBD

Principle Investigator: Ece Mutlu, MD, MS, MBA

Eligibility Criteria: The study is recruiting three groups: Active Disease, New Disease and Remission (longitudinal study only). To participate in this study, all participants must:

• Be a non-smoker or have no change in smoking habits in the past month
• Be born and raised in the United States
• Have a stable weight with stable dietary habits over the last year
• Be of a healthy weight

Additionally, the following criterion applies for each group:

For the Active Disease group, patients must:

• Have documented Ulcerative Colitis or Crohn's Disease
• Have chronic active Inflammatory Bowel Disease (IBD) for at least 2 weeks

For the New Disease Group, patients must:

• Have symptoms of intermittent recurrent bloody diarrhea, abdominal pain or weight loss

For the Remission Group (longitudinal study ONLY), patients must:

• Have documented ulcerative colitis or ileocolonic or colonic Crohn's Disease
• Be in remission for the six months preceding the study
• Inactive IBD for at least 2 weeks as determined by clinical indices

Study Description

The study is examining dysbiosis in IBD using both a cross-sectional and longitudinal approach. The cause of Inflammatory Bowel Disease (IBD) is not yet known. It has been speculated that variation in the bacterial composition of the colon may play a key role in the development of disease.

Patients in the Cross-Sectional Study

Patients in this study will undergo a colonoscopy (as clinically indicated and prescribed) or flexible sigmoidoscopy during which time tiny tissue samples called biopsies will be collected. These samples will be sent to a laboratory where bacteria will be isolated and identified. Comparisons will then be made to evaluate any differences between the bacteria found in healthy persons versus persons with disease. Participants will also fill out several symptom and diet history questionnaires and receive study related blood work at no charge. This study requires four visits over a period of 14 days.

Patients in the Longitudinal Study

Patients in this study will undergo a colonoscopy (as clinically indicated) or flexible sigmoidoscopy during which time tiny tissue samples called biopsies will be collected. These samples will be sent to a laboratory where bacteria will be isolated and identified. Comparisons will then be made to evaluate any differences between the bacteria found in healthy persons versus persons with disease. Participants will also fill out several symptom and diet history questionnaires and receive study related blood work at no charge. This study requires four visits over the period of one year.

Compensation: Patients in the longitudinal study will be reimbursed up to $150 depending upon completion of the study.

Crohn's Disease and Ustekinumab Therapy

Principal Investigator: Ece Mutlu, MD, MS, MBA

Eligibility Criteria: You may be eligible for this study if you meet the following criteria:

• Are at least 18 years of age or older
• Have had Crohn's disease for at least 3 months
• Have received previous treatment that did not work

Study Description

The purpose of this study is to determine whether or not treatment with an experimental drug called Ustekinumab and whether or not the treatment will reduce the symptoms of Crohn’s disease in adult patients who have moderate to severe Crohn’s disease.

Participants in this study will receive the following free of charge:

• Physician visits
• Study related bloodwork and procedures
• Study related medication
• Parking/Transportation reimbursement