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Bile Acid

Ursodeoxycholic Acid for Pouchitis

Phase 2 & 3

Recruiting

Led By Sidhartha Sinha, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have chronic antibiotic refractory or antibiotic dependent pouchitis.

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

Must not have

History of regular nonsteroidal anti-inflammatory drugs (NSAID) use

Pancreatic maldigestion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from screening, at week 6 and at end of treatment (10 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if ursodeoxycholic acid may help people with active pouchitis who haven't been helped by antibiotics or who need to keep taking antibiotics.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, common side effects of UDCA may include mild diarrhea, nausea, upset stomach; however individual experiences may vary. Participants will be monitored for any adverse reactions throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pouchitis hasn't improved with antibiotics or needs continuous antibiotics.

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My internal exam shows significant inflammation.

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I have pouchitis that hasn't improved with antibiotics.

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I am over 18 and had surgery for ulcerative colitis.

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I am over 18 and had surgery to connect my small intestine to my anus due to ulcerative colitis.

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My internal examination score is 2 or higher, not counting the area near surgical stitches.

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I have more than 6 bowel movements a day, which is more than 3 above my normal rate after IPAA surgery.

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I have more than 6 bowel movements a day after my IPAA surgery.

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I have changes in my bowel movements.

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I have had pouchitis before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use NSAIDs for pain or inflammation.

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My pancreas does not digest food properly.

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I have a narrowing in my body where two sections were surgically connected.

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I have had cancer before, but only skin cancer that did not spread.

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I have trouble absorbing nutrients from my food.

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I have bowel control issues due to anal muscle problems.

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I have had a fecal transplant in the last 12 weeks.

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I am not using any rectal medications.

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I have been on special feeding through a tube or IV in the last 2 weeks.

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I am using or willing to use effective birth control or am surgically sterile.

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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.

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I am not pregnant or breastfeeding.

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I haven't taken more than 6.0 mg/day of budesonide, nor changed its dose in the last 4 weeks.

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I have been on a stable dose of immunosuppressant therapy for at least 8 weeks.

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I cannot undergo an endoscopy.

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I have Crohn's disease affecting my pouch, with either complex fistulas or deep ulceration.

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I do not have an infection in my pelvic area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from screening, at week 6 and at end of treatment (10 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from screening, at week 6 and at end of treatment (10 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from screening, at week 6 and at end of treatment (10 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects who achieve clinical response at week 10.

Secondary study objectives

Mean change in C-reactive protein (CRP)

Mean change in Cleveland Global Quality of Life (CGQL)

Mean change in erythrocyte sedimentation rate (ESR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 27Eligibility criteria met