Evaluation of the Relationship Between Pouch Function and Pouch Inflammation in Patients with Ulcerative Colitis

Overview

About this study

The purpose of this study is to find out if there is a relationship between pouch function (the ability to completely evacuate or empty the pouch) and the development of inflammation in the pouch.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 18 years or older
  • Confirmed diagnosis of ulcerative colitis (UC) and a history of total abdominal colectomy (TAC) with ileal pouch anal anastomosis (IPAA)
  • Closure of ileostomy, with reinstitution of fecal stream through the ileal pouch, at least 3 years prior to enrollment in the study
  • Ability to understand study procedures and to comply with them for the entire length of the study.
  • Men and women of reproductive capability will be enrolled.  Contraception is not required, although a negative urine pregnancy test will be required in all women immediately prior to participation in the study.  

Exclusion Criteria:

  • Female patients who are pregnant (a urine pregnancy test will be performed prior to study procedures)
  • Patients who are on blood thinners, unable to hold for 5 days prior to visit 1, per physician
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Patients with symptoms suggestive of active inflammation (increase in bowel frequency > 3 bowel movements over baseline, bleeding, urgency, or fever > 100.5°F)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Laura Raffals, M.D.

Closed for enrollment

Contact information:

Shawn Haren B.S., C.C.R.C.

(480) 301-6083

Haren.Shawn@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20156048

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