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Ulcerative ColitisPhase 2/3NCT03724175

The Role of Secondary Bile Acids in Intestinal Inflammation

A Phase 2/3 study testing ursodiol (ursodeoxycholic acid, UDCA) in people with Ulcerative Colitis and Pouchitis, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Ulcerative Colitis, Pouchitis
What is being tested?
ursodiol (ursodeoxycholic acid, UDCA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
26 Aug 2019to 2 Mar 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Documented evidence of active pouchitis, based on endoscopy, symptoms and histopathology, as follows:
  • 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):
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  • 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.
  • Histology: evidence of disease.
  • Modified PDAI (mPDAI) score >= 5. The mPDAI consists of the symptom (range: 0-6) and endoscopy (range: 0-6) subscores.
  • Must have chronic antibiotic refractory or antibiotic dependent pouchitis.

Who cannot join

  • 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.
  • Women who are pregnant or breastfeeding;
  • 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:
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  • 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.
  • Use of rectal compounds is not permitted; these agents must be discontinued at the Screening Visit.
  • Immunosuppressant therapy (azathioprine, 6- mercaptopurine, methotrexate, cyclosporin); exclude subjects who have received treatment for < 12 weeks, or who have changed doses within 8 weeks of the Screening Visit.
  • Biological agents (Anti-tumour necrosis factor (anti - TNF) therapy, vedolizumab and / or ustekinumab); exclude subjects who have received biological agents for <6 months prior to the screening visit, or who changed doses of the biological agent within 6 months prior to the screening visit.
  • Previous use of UDCA is permitted: treatment course must have completed at least 12 weeks prior to the Screening Visit.
  • All other agents targeted to pouchitis, including experimental agents, must have been discontinued at least 8 weeks prior to the Screening Visit, or for a period equivalent to 5 half-lives (t1⁄2) of the agent (whichever is longer) It is acceptable to recruit subjects who remain on optimised, stable doses of oral 5-ASA, oral steroids (below the doses stipulated above) and immunosuppressants.
  • It is acceptable to recruit subjects who terminated treatment with oral 5-ASA or oral steroids 4 weeks before the Screening Visit, or immunosuppressants 8 weeks before the Screening Visit.
  • Note: Analgesic use should remain stable throughout the trial where possible. Paracetamol is the analgesic of choice.
  • Note: VSL#3 probiotic treatment (and other probiotic treatments) will be permitted as long as maintained stable for 4 weeks prior to the Screening Visit, and maintained at a stable dose throughout the trial
  • Also excluded are subjects with:
  • Anastomotic stricture
  • Unable to undertake endoscopic evaluation
  • Faecal incontinence due to anal sphincter dysfunction
  • Infections to cytomegalovirus or Clostridium Difficile
  • Faecal transplantation within 12 weeks of screening
  • Intestinal malabsorption
  • Pancreatic maldigestion
  • Suspected irritable pouch syndrome
  • Cuffitis (inflammation of the anal mucosa). Subjects with active antibiotic refractory pouchitis as the predominant condition, but who also have cuffitis, may be enrolled
  • Crohn's disease of the pouch; defined as either: a) complex perianal or pouch fistula and/or b) extensive pre-pouch ileitis with deep ulceration
  • Subjects with a history of neoplastic disease except for basal cell carcinoma or nonmetastatic squamous cell carcinoma of the skin
  • Subjects who are receiving or have received nasogastric/nasoenteric bottle feeding, an elemental diet, or total parenteral nutrition within the 2 weeks prior to Day 1
  • Subjects with a history of clinically significant and/or persistent haematologic, renal, hepatic, metabolic, psychiatric, central nervous system, pulmonary or cardiovascular disease; which in the investigator's opinion, would exclude entry into the study
  • Subjects with any laboratory tests considered clinically significant at screening
  • Subjects who may be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason including, for example, inability to retain an enema formulation
  • Pelvic sepsis should be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Being tested
ursodiol (ursodeoxycholic acid, UDCA)
Keywords
Ulcerative Colitis, Pouchitis
Medical subject headings
Colitis, Ulcerative, Pouchitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ursodiol (ursodeoxycholic acid, UDCA)Drug

    Also called NDC 0591-3159-01 Ursodiol Capsules, USP 300 mg

    ursodiol (ursodeoxycholic acid, UDCA) 300 mg two times daily for 10 weeks for UC pouchitis patients

Study groups in NCT03724175
Study groupRoleWhat they receive
ursodiol (ursodeoxycholic acid, UDCA)Experimentalursodiol (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
Receives: Drug: ursodiol (ursodeoxycholic acid, UDCA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects who achieve clinical response at week 10.

    Clinical response is defined as reduction of mPDAI score by >=2 points.

    Measured: change from screening to end of treatment (10 weeks)

Secondary outcomes (8)

  1. Proportion of subjects who achieve remission at week 10.

    Remission is defined as mPDAI < 5 and reduction of mPDAI score by >=2 points.

    Measured: change from screening at end of treatment (10 weeks)

  2. Proportion of subjects who achieve endoscopic response at week 10.

    Endoscopic response is defined as reduction of modified MAYO (mMAYO)score by >=1 point.

    Measured: change from screening at end of treatment (10 weeks)

  3. Proportion of subjects who achieve endoscopic remission at week 10.

    Endoscopic remission is defined as mMAYO score <=1.

    Measured: change from screening at end of treatment (10 weeks)

  4. Proportion of subjects with a stool frequency represented by a Mayo subscore of <1 at Week 10.

    Proportion of subjects with a stool frequency represented by a Mayo subscore of <1 at Week 10.

    Measured: change from screening at the end of treatment (10 weeks)

  5. Mean change in Cleveland Global Quality of Life (CGQL)

    Cleveland Global Quality of Life questionnaire (including current quality of life [0 being the worst and 10 being the best] ; current quality of health [0 being the worst and 10 being the best]; current energy level [0 being the worst and 10 being the best])

    Measured: change from screening, at week 6 and at end of treatment (10 weeks)

  6. Mean change in erythrocyte sedimentation rate (ESR)

    Mean change from baseline in erythrocyte sedimentation rate (ESR) at Week 6 and Week 10.

    Measured: change from screening, at week 6 and at end of treatment (10 weeks)

  7. Mean change in C-reactive protein (CRP)

    Mean change from baseline in C-reactive protein (CRP) at Week 10.

    Measured: change from screening, at week 6 and at end of treatment (10 weeks)

  8. Mean change in fecal calprotectin

    Mean change from baseline in fecal calprotectin at Week 10

    Measured: change from screening, at week 6 and at end of treatment (10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start26 Aug 2019
  3. Primary completion2 Mar 2026
  4. Study completion2 Mar 2026

Why it stopped: Lack of recruitment and funding.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03724175
Sponsor's protocol ID
IRB-47198
Status last verified
Mar 2026
First submitted
12 Oct 2018
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Weingarden AR, Chen C, Zhang N, Graiziger CT, Dosa PI, Steer CJ, Shaughnessy MK, Johnson JR, Sadowsky MJ, Khoruts A. Ursodeoxycholic Acid Inhibits Clostridium difficile Spore Germination and Vegetative Growth, and Prevents the Recurrence of Ileal Pouchitis Associated With the Infection. J Clin Gastroenterol. 2016 Sep;50(8):624-30. doi: 10.1097/MCG.0000000000000427.

    PubMed 26485102

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing ursodiol (ursodeoxycholic acid, UDCA) in people with Ulcerative Colitis and Pouchitis, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of recruitment and funding.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who achieve clinical response at week 10. (time frame: change from screening to end of treatment (10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03724175, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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