Clinical Research Details

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

Study Description

This research study is for individuals who have inflammatory bowel disease (IBD), including Crohn’s disease (CD), ulcerative colitis (UC), and Indeterminate Colitis (IBDU). These are chronic inflammatory disorders of the gastrointestinal (GI) tract. The goals of this study are to collect information on patients with IBD to determine the natural course of the disease and to determine how procedures or treatments that may be recommended by your doctors may affect IBD and general health.

This is an observational study. Participating in this study does not change anything that the participant's physician will do or has already done to treat or manage the participant's IBD. Decisions about the types of therapies, length (duration), and dosing are determined by the participant and the physician. If an individual agrees to participate in this study, the participant's past (up to three years before enrolling in the study) and future (up to 5 years from the date of enrollment) medical records will be collected and sent to the sponsor to be stored in a private and secure database. The participant's name and contact information will be removed from the medical records by a member of the study doctor’s staff (this is a process called “redaction”) and replaced by a unique study participant number (code) before sending the records to the sponsor. In addition to participating in the main part of the study, one may be asked to participate in three additional parts of the study which are optional. These are referred to as “sub-studies.”

Inclusion/Exclusion Criteria

Inclusion Criteria:

  1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial.
  2. Have plans for future visits at the site for continued management of IBD.
  3. Inability to provide written informed consent/assent.
  4. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries).
  5. Prior total abdominal colectomy for UC or IBDU.

Investigators