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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from screening, at week 6 and at end of treatment (10 weeks)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My pouchitis hasn't improved with antibiotics or needs continuous antibiotics.
Select...
My internal exam shows significant inflammation.
Select...
I have pouchitis that hasn't improved with antibiotics.
Select...
I am over 18 and had surgery for ulcerative colitis.
Select...
I am over 18 and had surgery to connect my small intestine to my anus due to ulcerative colitis.
Select...
My internal examination score is 2 or higher, not counting the area near surgical stitches.
Select...
I have more than 6 bowel movements a day, which is more than 3 above my normal rate after IPAA surgery.
Select...
I have more than 6 bowel movements a day after my IPAA surgery.
Select...
I have changes in my bowel movements.
Select...
I have had pouchitis before.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who achieve clinical response at week 10.
Secondary outcome measures
Mean change in C-reactive protein (CRP)
Mean change in Cleveland Global Quality of Life (CGQL)
Mean change in erythrocyte sedimentation rate (ESR)
+5 moreTrial 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
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,580 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
247 Patients Enrolled for Ulcerative Colitis
Sidhartha Sinha, MDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
190 Total Patients Enrolled
1 Trials studying Ulcerative Colitis
21 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pouchitis hasn't improved with antibiotics or needs continuous antibiotics.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 haven't taken any biological agents for my condition in the last 6 months.I finished my UDCA treatment at least 12 weeks ago.My internal exam shows significant inflammation.My tests show signs of disease.My medication for pouchitis has been stable and will not change during the study.I might have irritable pouch syndrome.I have had cancer before, but only skin cancer that did not spread.I stopped any pouchitis-specific treatments at least 8 weeks ago, but I may still be on low-dose oral steroids or immunosuppressants.I have trouble absorbing nutrients from my food.I have pouchitis that hasn't improved with antibiotics.I haven't changed my strong pain medication dose in the last 4 weeks.I have bowel control issues due to anal muscle problems.I have had a fecal transplant in the last 12 weeks.I will keep my painkiller use constant, preferably using paracetamol.I am not using any rectal medications.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.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 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 have been taking the same dose of VSL#3 or another probiotic for at least 4 weeks.I cannot undergo an endoscopy.I have Crohn's disease affecting my pouch, with either complex fistulas or deep ulceration.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 do not have an infection in my pelvic area.My internal examination score is 2 or higher, not counting the area near surgical stitches.I will use effective birth control during and for 30 days after the study.You have had an allergic reaction or bad side effects from UDCA before.I have not changed or stopped my oral 5-ASA medication in the last 4 weeks.I have inflammation in my anal area and my condition hasn't improved with antibiotics.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 confirmed active pouchitis with tests.My tests show signs of disease.I have changes in my bowel movements.I have had pouchitis before.
Research Study Groups:
This trial has the following groups:- Group 1: ursodiol (ursodeoxycholic acid, UDCA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT03724175 — Phase 2 & 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total number of participants that this research can have?
"Yes, the data on clinicaltrials.gov suggests that this study is currently recruiting participants. The trial was first posted on 8/26/2019 and was most recently edited on 5/3/2022. The clinical trial is enrolling 15 participants across 1 sites."
Answered by AI
Could you please list other scientific papers that have looked at ursodiol?
"At this moment in time, there are a total of 18 ursodiol (ursodeoxycholic acid, UDCA) clinical trials underway. Out of these, 10 are in Phase 3. Most of these studies are situated in Xi'an, Shaanxi; however, there are 65 locations running ursodiol (ursodeoxycholic acid, UDCA) clinical trials in total."
Answered by AI
If I wanted to, could I become a test subject for this experiment?
"This study is looking for 15 individuals, aged 18 to 70, who have a medical history of pouchitis. To be eligible, potential participants must meet the following requirements: an increased stool frequency in comparison to what is considered normal after their IPAA operation, a score of 2 or more on the endoscopic component of a modified Mayo endoscopic score, evidence of disease based on histology, and a modified PDAI score of 5 or more. In addition, candidates must have chronic antibiotic refractory or antibiotic dependent pouchitis."
Answered by AI
Does age limit a person's ability to participate in this experiment?
"Individuals that are looking to participate in this trial must be between 18-70 years old."
Answered by AI
Can people with the qualifying conditions join this trial at this time?
"Yes, this trial is still currently looking for participants, as reflected on the clinicaltrials.gov website. This study was first posted on August 26th, 2019 and the most recent update was on May 3rd, 2022."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
What questions have other patients asked about this trial?
do you need me and my PBC?
PatientReceived no prior treatments
Why did patients apply to this trial?
I have PBC and have been using ursodial for about 18 yrs.
PatientReceived 1 prior treatment
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