Assessment of Patients With Acute Pouchitis Treated With Antibiotics (NCT05252273) | Clinical Trial Compass
SuspendedNot Applicable
Assessment of Patients With Acute Pouchitis Treated With Antibiotics
Stopped: This decision has been made after careful consideration and evaluation of trial progress and ongoing recruitment challenges.
United States, Canada, Netherlands43 participantsStarted 2021-12-07
Plain-language summary
The purpose of this study is to evaluate the reliability and responsiveness of symptoms, endoscopic, and histological items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy for treatment of pouchitis, in order to develop a novel pouchitis disease activity index.
Who can participate
Age range
18 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:
* Adult patients ≥ 18 years of age
* IPAA for UC (J-pouch only) ≥ 6 months prior to screening
* Diagnosis of acute pouchitis at screening by stool frequency (an absolute value of ≥ 6 stools / day AND an increase of ≥ 3 stools / day above the post-IPAA baseline), and local endoscopy (presence of ≥ 1 erosion or ulceration of the pouch on endoscopy \[not including ulceration occurring within 1 cm of the pouch staple or pouch suture line\]).
* Not currently taking antibiotics for pouchitis or previous systemic antibiotic use for any reason within 4 weeks of screening. Prior to the Screening pouchoscopy. Note: Initiation of antibiotics for treatment of acute pouchitis prior to the Screening pouchoscopy will be permitted only if the participant initiates treatment within 48 hours prior to the Screening pouchoscopy; use outside of the 48-hour window will not be permitted and these patients should not be included in the study
* Current treatment with 5-aminosalicylic acid drugs, immunosuppressants, antidiarrheals, antimotility agents, and probiotics is permitted, if patient has received a stable dose for ≥ 4 weeks prior to screening. Dose of concomitant therapy must remain stable during the study period.
* Able to participate fully in all aspects of this clinical trial.
* Written informed consent must be obtained and documented
Exclusion Criteria:
* Pouch formations besides J-pouch (e.g., W-, S- and Kock pouches).
* IPAA for familial adenomatous polyposis.
* Po…
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
Change from Screening Clinical Global Impressions of Severity at Week 6
Timeframe: Baseline and Week 6
2
Change from Screening Patient's Global Impression of Severity at Week 6
Timeframe: Duration of study, approximately 6 weeks.
3
Symptoms and Impacts Questionnaire for Pouchitis
Timeframe: Duration of study, approximately 6 weeks
4
Visual Analog Scale for Pouchitis Symptoms
Timeframe: Duration of study, approximately 6 weeks
5
Visual Analog Scale of Fecal Urgency
Timeframe: Duration of study, approximately 6 weeks
6
Visual Analog Scale of Abdominal Cramps Severity
Timeframe: Duration of study, approximately 6 weeks
7
Change from Baseline St. Mark's Fecal Incontinence Score (Vaizey Score) at Week 6