The Role of Secondary Bile Acids in Intestinal Inflammation
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 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 those subjects with active antibiotic refractory or antibiotic dependent pouchitis.
• Written informed consent;
• Male or female subjects, ≥18 years of age who have undergone an ileal pouch-anal anastomosis (IPAA) for UC.
• History of pouchitis
• Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
• Endoscopic score \>=2 on the endoscopic component of a modified Mayo endoscopic score (where friability is scored as \>2) Note: the area within 1 cm of the pouch staple, or pouch suture line, is not considered evaluable
• Symptomatic disease (stool frequency):
• Subjects must demonstrate increased stool frequency compared to what is considered normal after their IPAA operation (baseline). Stool frequency must be an absolute value of \> 6 stools per day, and \> 3 stools per day above the post-IPAA baseline. Note: The measurement of stool frequency will be a 7-day average rounded to the nearest integer. The most recent 7 days of data will be used to calculate the average.
• Histology: evidence of disease.
• Modified PDAI (mPDAI) score \>= 5. The mPDAI consists of the symptom (range: 0-6) and endoscopy (range: 0-6) subscores.
• Must have chronic antibiotic refractory or antibiotic dependent pouchitis.