An Integrated Metagenomics and Immunoproteomics Study of the Role of Microbiome in Pouchitis Development

Overview

About this study

The primary purpose of this study is to establish an Arizona-based patient recruitment and sample collection infrastructure with a wide network of gastroenterologists in Maricopa County, including both academic and community gastroenterologists. Secondarily, they will analyze the pouch microbiota and anti-microbial antibodies in longitudinal samples collected from patients undergoing RPC with IPAA. We will compare data from patients who develop pouchitis and those who do not develop pouchitis to eventually identify antibody markers that can prognosticate pouchitis and understand the role of bacteria or immune response to them in pouchitis development.

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:

Age greater than or equal to 18 years.
Confirmed diagnosis of ulcerative colitis and/or dysplasia.
Subjects who are undergoing or have undergone a proctocolectomy with ileal pouch anal anastomosis and are scheduled for, or have had takedown of ileostomy at any time.
The patient is willing and able to sign the written, informed consent document.

Exclusion Criteria:

Female patients who are pregnant.
Patients that are unable to adhere to the protocol guidelines and/or schedule.
Patients unable to give informed consent.

Eligibility last updated 9/22/21. Questions regarding updates should be directed to the study team contact.

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
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Jonathan Leighton, M.D.	Closed for enrollment	Contact information: Brooke Brown (480) 301-4735 Brown.Brooke@mayo.edu

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jonathan Leighton, M.D.

Closed for enrollment

Contact information:

Brooke Brown

(480) 301-4735

Brown.Brooke@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials