Purpose of study:
Crohn’s Disease is a condition that causes swelling, redness, sores, and pain from the mouth to your bottom, and can cause diarrhea with or without blood. Some children with Crohn’s Disease develop problems such as narrowing of the intestines or blisters in the intestines. However, some children with IBD do not develop these problems. It is not known which children will develop these problems or how long it will take. Certain information stored in the immune system and genes, called “bio-markers”, could help doctors and scientists to identify children who are at risk of developing complications of Crohn’s Disease. We are doing this research study to identify “bio-markers” easily found in blood, stool, or in the lining of the intestines that can help doctors to know which children with Crohn’s Disease are at risk of developing complications quickly. This can help doctors to better treat patients.
Who can participate:
The study doctor must review all study patients to make sure they meet all of the requirements to be in the study. To be in the study, you must:
Be younger than or equal to 16 years of age.
Have a confirmed or suspected diagnosis of Crohn’s Disease (within the past 30 days).
Patients must be followed by the GI Clinic at Nationwide Children’s Hospital.
What will happen during the study:
This study will last for about 3 years, with 4 visits. Visits will be at Day 1, Month 12, Month 24 and Month 36. These visits will take place at the same time as your regularly scheduled clinic visits.
Blood Samples - If you participate in this study, about 2 teaspoons of blood will be taken at the first study visit. At Visits 2 -4, about 2 teaspoon of blood will be obtained for immune testing.
Stool Samples - You will be asked to provide a stool sample. This sample will be used to look at extremely small microorganisms called microflora, which are always living inside our intestines.
Data - Additional information will also be gathered from your medical chart. This will include information like your age at diagnosis, gender, race and ethnicity, birth history, past medical history, and family history. We will collect information from your regularly scheduled clinic visit as well as your study visits. If you are not seen in clinic at the time points required by the study, we may call you to ask specific medical questions.
Some patients participating in this study will have a colonoscopy as a part of their standard medical care. A colonoscopy is a procedure where a small, thin tube with a camera on the end is inserted into the rectum and into the intestines. During this procedure, doctors have the ability to take a “biopsy,” or a very small tissue sample about the size of a rice grain from the inside of the intestines. If you are scheduled for a colonoscopy, we would like to collect up to 6 biopsies during the procedure. We would only collect samples once. No further biopsies will be requested. Biomarkers identified in the samples from the intestines will be used to compare with bio-markers found in the blood and stool.
Who to contact:
Stacy Ballam 614-722-3004
Beth Skaggs 614-722-3487