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UBMD Physicians' Group

Clinical Trials

A Risk Stratification and Identification of Immunogenetic and Microbial Markers of Rapid Disease Progression in Children with Crohn's Disease.

Crohn's Disease (CD) is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sore) of the small and/or large intestines. Ulcerative Colitis (UC) is characterized by inflammation of the large intestine (colon). Indeterminate colitis (IC) is a sub-group of inflammatory bowel disease that cannot be characterized as either CD or UC. Patients with CD, UC, and IC suffer from symptoms such as diarrhea, abdominal pain, rectal bleeding, weight loss, difficulty growing, and fever. CD, UC, and IC can be treated with medications that suppress the immune system (the body system involved in inflammations and infections), or in some cases surgery. This research study is an observational study designed to gain information on pediatric patients with inflammatory bowel disease (IBD).

The purpose of the study is 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 develping complications quickly. This can help doctors to better treat patients.

Eligibility

Patients under 17 years of age at the time of study enrollment either undergoing a colonoscopy for suspected Inflammatory Bowel Disease or recently diagnosed with Crohn's Disease less than one month.

Requirements

Participants will be patients of the Digestive Diseases and Nutrition Center at Women & Children's Hospital of Buffalo and will either be undergoing a colonoscopy for suspected Inflammatory Bowel Disease or have recently (within 30 days) been diagnosed with Crohn's Disease. Additional biopsy, blood, and stool samples will be obtained for patients undergoing a colonoscopy and blood and stool samples will be obtained on patients newly diagnosed with IBD. Once confromed with IBD there will be biannual direct contact preferably a medical encounter (office visit) and reveiw of participant's medical record where the following will be collected: subjet's height, weight, information about participant's diseae and medication usage during the interval. The subject remains in the study for a total of three years post diagnosis of IBD.

Reimbursement

Subjects confirmed with Inflammatory Bowel Disease will receive $20 for each completed visit.

Investigator

Susan S. Baker, MD, PhD, Principal Investigator Robert D. Baker, MD, PhD, Sub-Investigator Daniel Gelfond, MD, Sub-Investigator Humaira Hashmi, MD, Sub-Investigator Anita M. Crawley, RN, PNP, Sub-Investigator Casey M. Gajewski, RN, PNP, Sub-Investigator

Contact Information

Name: Susan S. Baker, MD, PhD Christine M. Roach, RN, BSN, Study Coordinator
Phone: 716-878-7199
Email: croach@upa.chob.edu