Not Yet RecruitingPhase 1ACTRN12613000544774

Probiotic dietary supplement and stool evaluation to improve ileal pouch health

Patients with an ileal pouch for ulcerative colitis taking a probiotic for 8 weeks as an open label phase one study to assess its effect on pouch function, quality of life, and to evaluate any alteration in stool microbiota.


Sponsor

University of Otago

Enrollment

20 participants

Start Date

Jul 1, 2013

Study Type

Interventional

Conditions

Summary

An ileal pouch is formed when the end of the small bowel is used to create a pouch and anastomosed to the anus. This is required in patients who need removal of all their colon and rectum, most commonly for ulcerative colitis. The ileal pouch mucosa (or lining) exists in a state of a varying degree of chronic inflammation. When this is more severe clinical pouchitis develops. Pouchitis is most likely due to an alteration in the microbiota that the ileal mucosa is exposed to. The microbiota alter due to increased stasis of the contents of the ileal pouch, compared to ileum in the normal state. From our previous research and that of others, certain bacteria are associated with less inflammation and certain with more inflammation. We have selected a bacterial culture from previous research that is associated with a healthy pouch. We have been able to develop this bacterium into a probiotic. We wish to use this probiotic as a dietary supplement to see if we can improve the health, function and quality of life in ileal pouch patients.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria1

  • Functioning ileal J pouch for ulcerative colitis

Exclusion Criteria1

  • unable to provide informed consent

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Interventions

A freeze dried probiotic powder taken in one gelatin capsule taken twice a day for 8 weeks. Each capsule will contain 10^9 colony-forming units of (bacterium name) per capsule. To monitor complianc

A freeze dried probiotic powder taken in one gelatin capsule taken twice a day for 8 weeks. Each capsule will contain 10^9 colony-forming units of (bacterium name) per capsule. To monitor compliance at the end of 8 weeks all participants will be asked to return the dispensing container with any unused capsules.


Locations(1)

New Zealand

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