A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effectiveness of a Nutritional Intervention in Improving the Intestinal Mucosal Health Status in Subjects with Crohn’s Disease
Receiving Induction Anti-TNF Therapy
Total # of Subjects Needed:
The study will enroll approximately 240 subjects at approximately 40 sites in the United States.
What is the study product?
CROWN is a milk-based powder that is provided by the study sponsor and will be mixed with water and taken as a drink. You will be randomly assigned to one of the following:
- GROUP A: One serving (28.7 g) of CROWN twice a day, preferable more than 1 hour before or more than 2 hours after meals, for up to 24 weeks
- GROUP B: One serving of placebo twice a day, preferable more than 1 hour before or more than 2 hours after meals, for up to 24 weeks
You have a one in two chance of being assigned to the active study product (CROWN) and you have a one in two chance of being assigned to placebo.
You should take your study product while at home and never at the clinic. Once you are assigned to a treatment group you will continue in that treatment group as long as you stay in the study. Neither you nor your Study Doctor will know what study product you receive; however, this information is available to your Study Doctor if needed to treat a medical emergency.
CROWN is a medical food that may (or may not) help manage your CD. A medical food targets the dietary management of a specific disease or condition. CROWN has a high protein content consisting of whey and casein proteins (14 g per serving) and containing the amino acids threonine (3.3 g per serving), serine (2.75 g per serving), and proline (2.75 g per serving). Protein is common in foods such as meat, eggs and dairy products and helps to build, maintain and repair the tissue in the human body. Whey and casein proteins are naturally present in milk and are known for their well-balanced amino acid composition. Amino acids are the building blocks of proteins and therefore essential to human health.
If you decide to take part, what is involved?
If you decide to take part, your participation may last up to 33 weeks: you will be asked to come to the clinic for six visits and receive one study telephone call. If your health changes, you may also be asked to come to clinic for (an) unscheduled visit(s). The study is divided into three
parts: a Screening Period (Visit 1), an Assessment Period (Visits 2–6), and a Follow-Up Period (telephone call 30 days after your last visit). Before any study procedures are done, you will be asked to sign the informed consent form at the end of this document. If you consent to
participate, your Study Doctor will review your health history, medications, and test results to make sure you meet the study requirements.
Watch an excellent Chron’s Disease video HERE.
Apply for study
If you would like to learn more about the different study opportunities you may call 1-800-530-0998 or for local callers please call 801-356-5555. To apply for this study fill out the online application HERE.