Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Pouchitis
  • Ulcerative Colitis
Type
Interventional
Phase
Phase 2Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) ...

The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) continue to have inflammation similar to their previous disease. Only a few microbes are known to have the capability to modify primary bile acids (PBAs) made by the liver to secondary bile acids (SBAs). SBAs are some of the most common metabolites in the colon and play key roles in several diseases. In previous study, the investigators examined bile acid levels in stool from pouches (surgically-created "rectums" made of small bowel) in colectomy-treated patients with ulcerative colitis (UC) versus colectomy-treated controls without inflammatory disease. This comparison revealed that certain SBAs are significantly decreased in stool from UC compared to control pouches. In this study the investigators will investigate if ursodeoxycholic acid (UDCA) may reduce inflammatory markers and improve quality of life (as assessed by validate survey) in UC pouch patients (colectomy-treated patients with ulcerative colitis) with active antibiotic refractory or antibiotic dependent pouchitis.

Tracking Information

NCT #
NCT03724175
Collaborators
Not Provided
Investigators
Principal Investigator: Sidhartha Sinha, MD Stanford University