ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Pouchitis is a common, sometimes chronic complication after IPAA surgery for ulcerative colitis and can substantially affect quality of life. If topical 5-ASA prevents pouchitis, it could offer a simple prophylactic option for many post-surgery patients.
This trial directly tests whether mesalamine applied to the pouch reduces risk of pouchitis and will collect clinical, endoscopic, patient-reported, and mucosal-permeability data relevant to patients and clinicians.
Who Should Pay Attention
Adults with ulcerative colitis undergoing or considering IPAA surgery; clinicians who manage postoperative IBD care; researchers studying pouchitis prevention, topical therapies, and mucosal biomarkers.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment110 participants
Study statusNot_yet_recruiting
Source depthTrial registry record
What To Know
This is a randomized, double-blind, multicenter phase 4 trial (ASAPP) run in Sweden testing topical 5-ASA (mesalamine) versus placebo as prophylaxis to reduce pouchitis after ileal pouch–anal anastomosis (IPAA) for ulcerative colitis.
The study will enroll adult UC patients undergoing pouch surgery at national centers and follow them for pouchitis events using PDAI and endoscopic scoring, plus quality-of-life questionnaires and permeability testing. The trial’s primary outcome is any pouchitis event within two years (PDAI ≥7 with endoscopic severity).
Secondary aims include time to first pouchitis, rates at multiple timepoints, antibiotic/advanced-therapy responses after pouchitis, patient-reported outcomes, and mucosal permeability assessed with Ussing chambers. Enrollment status in the record is “Not Yet Recruiting” and this entry describes study design and planned outcomes rather than results.
This brief is based on the clinicaltrials.gov record and the study abstract provided there.
Keep In Mind
Record-level summary of a planned randomized clinical trial; does not contain results. The registry entry lists protocol aims, outcomes, and planned assessments; interpretation should wait for trial completion and peer-reviewed reporting.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorUniversity Hospital, Linkoeping
Trial IDNCT07773948
Study typeInterventional
Trial phasePhase 4
Enrollment110 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 19, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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