An interventional study of Intestinal Ultrasound in Ulcerative Colitis and Pouchitis, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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).
AIMS:
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 66 is close to the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Intestinal Ultrasound
Transabdominal and trans perineal ultrasound of the pouch
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.
Time frame: 2 hours per subject for ultrasound.
protocol goal was to enroll 109, only 66 subject signed consent, and took part in the study.
| Milestone | Patients With Pouchitis |
|---|---|
| Started | 66 |
| Completed | 55 |
| Not completed | 11 |
| Withdrew: Technical issue with ultrasound recording, data not used for analysis | 11 |
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.
| participants | Patients With Pouchitis |
|---|---|
| Diagnostic Accuracy of Intestinal Ultrasound (IUS) to Evaluate for Pouchitis Findings, Post Ileal Pouch-Anal Anastomosis-Number of Participants With Abnormal Ultrasound Findings | 33 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Pouchitis | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
unable to use information from 11 participants due to ultrasound technique.
| Age, Categorical(Participants) | Patients With Pouchitis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 34 |
| >=65 years | 21 |
| Age, Continuous(age) | Patients With Pouchitis |
|---|---|
| Mean | 55.11 (26.62 to 83.6) |
| Sex: Female, Male(Participants) | Patients With Pouchitis |
|---|---|
| Female | 19 |
| Male | 36 |
| Race and Ethnicity Not Collected(Participants) | Patients With Pouchitis |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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