Ulcerative ColitisNCT06316999
Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis
A study testing Intestinal Ultrasound in people with Ulcerative Colitis and Pouchitis, run by Mayo Clinic at 1 site in United States.
Trial summary
Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Pouchitis
- What is being tested?
- Intestinal Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 4 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18 years)
- Diagnosis of ulcerative colitis (UC)
- Status post ileal pouch anal anastomosis IPAA (completed all stages)
Who cannot join
- Pediatric patients
- Indeterminate colitis
- Status post IPAA for familial adenomatous polyposis (FAP)
- BMI > 30 kg/m2
- Pregnant
- Decompensated Cirrhosis
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis: A Prospective Pilot Study
Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).
Read the detailed description
AIMS:
- Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
- Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.
- Conditions
- Ulcerative Colitis, Pouchitis
- Being tested
- Intestinal Ultrasound
- Keywords
- Ileal Pouch Anal Anastomosis
- 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.
Intestinal UltrasoundDiagnostic test
Transabdominal and trans perineal ultrasound of the pouch
| Study group | Role | What they receive |
|---|---|---|
| Patients with Pouchitis | Other | Transabdominal and trans perianal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS. Receives: Diagnostic Test: Intestinal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings
Radiologists were blinded to pouchoscopy with biopsy results and evaluated the intestinal ultrasound of the pouch for each patient; assessing whether normal healthy pouch or inflammation was present. Those results were then compared to gold standard of pouchoscopy with biopsies to confirm accuracy. The number (n(%)) of participants with abnormal ultrasound findings confirmed with gold standard are reported.
Measured: 2 hours per subject for ultrasound.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jul 2024
- Primary completion4 Jun 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrell S. Pardi, M.D., Mayo Clinic
- Investigators
- Darrell Pardi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316999
- Sponsor's protocol ID
- 23-012169
- Status last verified
- Jul 2026
- First submitted
- 28 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Intestinal Ultrasound as a Diagnostic Tool for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT06316999
- Acronym / sponsor ID
- 23-012169
- Conditions
- Ulcerative Colitis, Pouchitis
- Keywords
- Ileal Pouch Anal Anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).
Detailed description
AIMS:
- Establish normal sonographic parameters in patients with an IPAA and normal pouch function.
- Evaluate the feasibility of IUS for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Pouchitis | Other | Diagnostic Test: Intestinal UltrasoundTransabdominal and trans perianal ultrasounds of the pouch will be performed by an experienced sonographer for each patient and interpreted by a board-certified radiologist specializing in IUS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (age ≥ 18 years)
- Diagnosis of ulcerative colitis (UC)
- Status post ileal pouch anal anastomosis IPAA (completed all stages)
Key exclusion criteria (7 listed)
- Pediatric patients
- Indeterminate colitis
- Status post IPAA for familial adenomatous polyposis (FAP)
- BMI > 30 kg/m2
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal UltrasoundTransabdominal and trans perineal ultrasound of the pouch | Diagnostic test | Patients with Pouchitis |
Primary outcome
Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings
Time frame: 2 hours per subject for ultrasound.
Radiologists were blinded to pouchoscopy with biopsy results and evaluated the intestinal ultrasound of the pouch for each patient; assessing whether normal healthy pouch or inflammation was present. Those results were then compared to gold standard of pouchoscopy with biopsies to confirm accuracy. The number (n(%)) of participants with abnormal ultrasound findings confirmed with gold standard are reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darrell Pardi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal Ultrasound in people with Ulcerative Colitis and Pouchitis, run by Mayo Clinic 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 12 Aug 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings (time frame: 2 hours per subject for ultrasound.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.