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The Role of Secondary Bile Acids in Intestinal Inflammation | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

The Role of Secondary Bile Acids in Intestinal Inflammation

NCT03724175•Stanford University

Summary

Detailed Description

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 previous study, the investigators examined bile acid levels in stool from pouches (surgically-created "rectums" made of small bowel) in colectomy-treated patients with ulcerative colitis (UC) versus colectomy-treated controls without inflammatory disease. This comparison revealed that certain SBAs are significantly decreased in stool from UC compared to control pouches. 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 UC pouch patients (colectomy-treated patients with ulcerative colitis) with active antibiotic refractory or antibiotic dependent pouchitis.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent;
•2. Male or female subjects, ≥18 years of age who have undergone an ileal pouch-anal anastomosis (IPAA) for UC.
•3. History of pouchitis
•Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
•4. 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
•5. 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.
•6. Histology: evidence of disease.
•7. Modified PDAI (mPDAI) score \>= 5. The mPDAI consists of the symptom (range: 0-6) and endoscopy (range: 0-6) subscores.
•8. Must have chronic antibiotic refractory or antibiotic dependent pouchitis.

Exclusion Criteria

•1. Lack of effective contraception Women of childbearing potential may not participate unless they are surgically sterile or are using adequate contraception.
•The following contraceptive methods are acceptable: hormonal (eg oral, injection, transdermal patch, implant, cervical ring), barrier (eg condom or diaphragm with spermicidal agent), intrauterine system or intrauterine device. If hormonal contraceptives are used by female subjects, they must be established for 6 weeks before the first administration of test product. Male sterilization is considered an acceptable form of contraception if the appropriate post-vasectomy documentation (absence of sperm) is provided in the subject's medical notes. Sexual abstinence is considered acceptable if this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (eg calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
•Male subjects with female partners of child-bearing potential and female subjects who are neither surgically sterilized nor post-menopausal (defined as no menses for one year or a follicle-stimulating hormone value \> 40 IU/L) will be required to use effective contraception throughout the study and for 30 days after.
•2. Women who are pregnant or breastfeeding;
•3. History of allergy or adverse event to UDCA;
•Stable use of concomitant medications for pouchitis is generally permitted, doses of concomitant medication, where taken, should be optimised in accordance with local/national practice guidelines, and dose levels and types of baseline medications for pouchitis will be documented and any changes during the study will be recorded. Changes in use of medications for pouchitis and high doses of oral steroids are not permitted. It is particularly important to maintain stable medication through to measurement of the primary end-point at Week 10. Criteria which would lead to exclusion of subjects from the study are described below:
•4. Changes in dose to strong analgesia, such as opioid containing compounds within 4 weeks of the Screening Visit.
•5. History of regular nonsteroidal anti-inflammatory drugs (NSAID) use.
•6. 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.
•7. 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.
+26 more criteria

Locations (1)

Stanford University

Stanford, California, United States

Key Dates

Start Date

August 26, 2019

Primary Completion Date

March 2, 2026

Completion Date

March 2, 2026

Last Updated

March 11, 2026

Enrollment

ACTUAL participants

Conditions

Ulcerative ColitisPouchitis

Interventions

ursodiol (ursodeoxycholic acid, UDCA)

DRUG

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

View study

RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE2

CLF065 for Chronic Pouchitis

NCT07226050

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Role of Secondary Bile Acids in Intestinal Inflammation

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

CLF065 for Chronic Pouchitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)