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NCT07773948 · ClinicalTrials.gov record · last posted 2026-08-19

ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery

Study acronym: ASAPP
StatusNot Yet Recruiting
PhasePhase 4
Started2027-04-01
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from the ClinicalTrials.gov record
Ulcerative colitis (UC) is a chronic intestinal disease, often debuting early in life, and affecting the colon and rectum. The therapy is mainly medical and based on 5-aminosalicylic acid (5-ASA) and steroids. The last 20 years numerous new advanced therapies have become available and introduced more and more early after diagnosis. Surgery is still needed in refractory disease and will cure most patients, while ending up with a stoma. There is conflicting data on whether advanced therapies are decreasing the need for surgery or not. Reconstruction of bowel continuity is usually possible but somehow performed in less than 50% of Swedish patients. Restorative proctectomy with ileal pouch (created of the last part of the small bowel) anal anastomosis (IPAA) is gold standard. As of this year it is centralized to 4 units in Sweden. One complication after IPAA is pouchitis, an inflammation in the pouch that behaves like UC. More than half of all patients will have at least one flare of pouchitis, and some will develop chronic or recurrent pouchitis. Recent publications have shown an increased risk of pouchitis after the introduction of advanced therapies, but the reasons for this are still unknown. Prophylactic therapy with 5-ASA after IPAA surgery have been suggested. All patients in Sweden going through IPAA surgery due to UC will be invited to be part of this randomized controlled study to evaluate if 5-ASA can diminish the risk of pouchitis in UC.
Trial Details
NCT Number NCT07773948
Lead Sponsor University Hospital, Linkoeping
Collaborators: Karolinska University Hospital, Skane University Hospital, Region Örebro County, Örebro University, Sweden, Karolinska Institutet, Östra Hospital, Göteborg University, Lund University
Conditions Ulcerative Colitis (UC), Pouchitis
Enrollment 110 participants
Start Date 2027-04-01
Primary Completion 2031-03-31 (estimated)
Study Completion 2031-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-19