The Role of Secondary Bile Acids in Intestinal Inflammation (NCT03724175) | Clinical Trial Compass
TerminatedPhase 2/3
The Role of Secondary Bile Acids in Intestinal Inflammation
Stopped: Lack of recruitment and funding.
United States2 participantsStarted 2019-08-26
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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):
. Histology: evidence of disease.
. Modified PDAI (mPDAI) score \>= 5. The mPDAI consists of the symptom (range: 0-6) and endoscopy (range: 0-6) subscores.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects who achieve clinical response at week 10.
Timeframe: change from screening to end of treatment (10 weeks)
. Must have chronic antibiotic refractory or antibiotic dependent pouchitis.
Exclusion criteria
. Lack of effective contraception Women of childbearing potential may not participate unless they are surgically sterile or are using adequate contraception.
. Women who are pregnant or breastfeeding;
. History of allergy or adverse event to UDCA;
. Changes in dose to strong analgesia, such as opioid containing compounds within 4 weeks of the Screening Visit.
. History of regular nonsteroidal anti-inflammatory drugs (NSAID) use.
. Oral 5-aminosalicylate (5-ASA) compounds; exclude subjects who have discontinued or changed doses of oral 5-ASA within 4 weeks of the Screening Visit.
. Oral budesonide \> 6.0 mg/day is not permitted; exclude subjects who have received budesonide for \< 6 weeks, or who have changed doses of budesonide within 4 weeks of the Screening Visit.
. Oral steroids other than budesonide: exclude subjects who exceed a daily dose of 15 mg prednisolone or equivalent, who have received oral steroids for \< 6 weeks, or who have changed dose within 4 weeks of the Screening Visit.