Ursodeoxycholic Acid for Pouchitis
Palo Alto (17 mi)Overseen bySidhartha Sinha, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Stanford University
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Is the drug Ursodeoxycholic Acid (UDCA) a promising treatment for pouchitis?Ursodeoxycholic Acid (UDCA) is a promising drug because it is effective in treating various liver and bile-related conditions, like primary biliary cirrhosis and gallstones. It also has potential benefits in reducing immune-related issues and may help in colon cancer protection.23678
What safety data exists for Ursodeoxycholic Acid (UDCA) treatment?Ursodeoxycholic Acid (UDCA) has been studied in various contexts, showing it is generally considered nontoxic and effective for different conditions. It has been used in trials for preventing colorectal adenoma recurrence, treating Clostridium difficile-associated ileal pouchitis, and reducing acute cardiac allograft rejection. UDCA is also used for treating cholestatic conditions and dissolving gallstones. These studies suggest a favorable safety profile, but specific safety data for pouchitis treatment may require further investigation.12579
What data supports the idea that Ursodeoxycholic Acid for Pouchitis is an effective treatment?The available research shows that Ursodeoxycholic Acid (UDCA) can inhibit the growth of Clostridium difficile, a bacteria associated with ileal pouchitis. This suggests that UDCA might be effective in treating pouchitis linked to this infection. However, the research does not provide direct evidence of UDCA's effectiveness specifically for pouchitis, as it mainly focuses on its potential to prevent recurrence of the condition when associated with Clostridium difficile infection.45789
Do I have to stop taking my current medications for the trial?The trial allows stable use of medications for pouchitis, but changes in medication are not permitted during the study. Some medications must be stopped or stabilized before the trial: oral 5-ASA and oral steroids 4 weeks prior, immunosuppressants 8 weeks prior, and biological agents 6 months prior to the screening visit. Rectal compounds must be discontinued at the screening visit. Please consult with the trial team for specific guidance on your medications.
Eligibility Criteria
Adults over 18 with a history of pouchitis after ileal pouch-anal anastomosis for ulcerative colitis, who have chronic antibiotic refractory or dependent pouchitis. They must show increased stool frequency and have evidence of disease through endoscopy and histology. Pregnant women, those allergic to UDCA, using certain medications or with significant other diseases are excluded.Inclusion Criteria
My pouchitis hasn't improved with antibiotics or needs continuous antibiotics.
My internal exam shows significant inflammation.
I have pouchitis that hasn't improved with antibiotics.
I am over 18 and had surgery for ulcerative colitis.
I am over 18 and had surgery to connect my small intestine to my anus due to ulcerative colitis.
My internal examination score is 2 or higher, not counting the area near surgical stitches.
I have more than 6 bowel movements a day, which is more than 3 above my normal rate after IPAA surgery.
I have more than 6 bowel movements a day after my IPAA surgery.
I have changes in my bowel movements.
I have had pouchitis before.
Exclusion Criteria
I regularly use NSAIDs for pain or inflammation.
My pancreas does not digest food properly.
I have a narrowing in my body where two sections were surgically connected.
I have had cancer before, but only skin cancer that did not spread.
I have trouble absorbing nutrients from my food.
I have bowel control issues due to anal muscle problems.
I have had a fecal transplant in the last 12 weeks.
I am not using any rectal medications.
I have been on special feeding through a tube or IV in the last 2 weeks.
I am using or willing to use effective birth control or am surgically sterile.
I haven't taken more than 15 mg of oral steroids daily, except for budesonide, for less than 6 weeks or changed my dose in the last 4 weeks.
I am not pregnant or breastfeeding.
I haven't taken more than 6.0 mg/day of budesonide, nor changed its dose in the last 4 weeks.
I have been on a stable dose of immunosuppressant therapy for at least 8 weeks.
I cannot undergo an endoscopy.
I have Crohn's disease affecting my pouch, with either complex fistulas or deep ulceration.
I do not have an infection in my pelvic area.
Treatment Details
The trial is testing whether the drug ursodeoxycholic acid (UDCA) can reduce inflammation in patients with active antibiotic refractory or dependent pouchitis by altering bile acids in the intestine. The study will assess if UDCA improves inflammatory markers and quality of life.
1Treatment groups
Experimental Treatment
Group I: ursodiol (ursodeoxycholic acid, UDCA)Experimental Treatment1 Intervention
ursodiol (ursodeoxycholic acid, UDCA) 300 mg two times daily for 10 weeks to treat pouchitis in ulcerative colitis patients with antibiotic refractory or antibiotic dependent pouchitis
Find a clinic near you
Research locations nearbySelect from list below to view details:
Stanford UniversityStanford, CA
Loading ...
Who is running the clinical trial?
Stanford UniversityLead Sponsor
References
Beneficial effect of ursodeoxycholic acid on mucosal damage in trinitrobenzene sulphonic acid-induced colitis. [2013]Recently we observed that ursodeoxycholic acid (UDCA) ameliorates an experimental small intestinal inflammation induced by indomethacin in the rat. In this study, we have tested whether ursodeoxycholic acid also reduces mucosal damage in the bile-independent trinitrobenzene sulphonic acid (TNB) model of experimental colitis.
Adjuvant treatment with ursodeoxycholic acid may reduce the incidence of acute cardiac allograft rejection. [2013]The nontoxic bile acid, ursodeoxycholic acid (UDCA), is an effective drug for the treatment of different cholestatic conditions. Furthermore, an immunomodulatory capacity of UDCA has been reported in vitro, as well as in vivo, in different immune-mediated liver diseases and after liver transplantation.
Bioavailability of four ursodeoxycholic acid preparations. [2019]Ursodeoxycholic acid (UDCA) is the drug of choice for treating primary biliary cirrhosis and dissolving cholesterol gallstones.
Changes in bile acid composition and effect on cytolytic activity of fecal water by ursodeoxycholic acid administration: a placebo-controlled cross-over intervention trial in healthy volunteers. [2019]Ursodeoxycholic acid (UDCA) has been shown to affect membrane-damaging effects of bile acids in vitro and fecal bile acid composition in rats. This study evaluates the effect of UDCA on fecal bile acid composition and on cytolytic activity of fecal water in man to clarify the potential chemopreventive role of UDCA for colorectal cancer.
Phase III trial of ursodeoxycholic acid to prevent colorectal adenoma recurrence. [2022]Ursodeoxycholic acid (UDCA) treatment is associated with a reduced incidence of colonic neoplasia in preclinical models and in patients with conditions associated with an increased risk for colon cancer. We conducted a phase III, double-blind placebo-controlled trial of UDCA to evaluate its ability to prevent colorectal adenoma recurrence.
A new amino acid derivative of ursodeoxycholate, (N-L-Glutamyl)-UDCA (UDCA-Glu), to selectively release UDCA in the colon. [2013]Ursodeoxycholic acid (UDCA) is chemoprotective in animal models of colon cancer but results from clinical trials have been less impressive probably because UDCA is rapidly absorbed in the small intestine and little reaches the colon. UDCA-glutamate (Glu), a novel bile acid, was synthesized with the objective of utilizing peptide bond cleavage by brush border enzymes to enhance delivery of UDCA to the colon.
Multi-enzymatic one-pot reduction of dehydrocholic acid to 12-keto-ursodeoxycholic acid with whole-cell biocatalysts. [2013]Ursodeoxycholic acid (UDCA) is a bile acid of industrial interest as it is used as an agent for the treatment of primary sclerosing cholangitis and the medicamentous, non-surgical dissolution of gallstones. Currently, it is prepared industrially from cholic acid following a seven-step chemical procedure with an overall yield of 99.5 mM 12-keto-UDCA within 4.5 h in a simple batch process on a liter scale.
Effect of 6-8 weeks of oral ursodeoxycholic acid administration on serum concentrations of fasting and postprandial bile acids and biochemical analytes in healthy dogs. [2016]Ursodeoxycholic acid (UDCA) is commonly used for the treatment of hepatobiliary disease. UDCA is a bile acid that can be detected in the bile acid assay. Its effect on biochemical analytes is unknown.
Ursodeoxycholic Acid Inhibits Clostridium difficile Spore Germination and Vegetative Growth, and Prevents the Recurrence of Ileal Pouchitis Associated With the Infection. [2020]To test whether ursodeoxycholic acid (UDCA) is inhibitory to Clostridium difficile and can be used in the treatment of C. difficile-associated ileal pouchitis.