Dietary Treatment of Crohn’s disease

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

Participants will also receive $200 for successful completion of 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 nonmedication or surgical strategies for maintaining Crohn’s disease in remission.

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

This is a partial list of eligibility requirements. To inquire about your eligibility, call the contact number provided. If you choose to respond via e-mail, please refer to the study title in your message.