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Studies

Interventional Not yet recruiting Phase 4

NCT07773948 on ClinicalTrials.gov

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

Official title: ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery, a Double Blinded Randomized Controlled Trial

  • Sponsor: Linkoeping University
  • Collaborators: Karolinska University Hospital, Skane University Hospital, Region Örebro County, Örebro University, Sweden, Karolinska Institutet, Östra Hospital, Göteborg University, Lund University
  • Enrollment: 110 (Estimated)
  • Study start: 2027-04-01 (Estimated)
  • Primary completion: 2031-03-31 (Estimated)
  • Study completion: 2031-03-31 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Single Group
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Prevention

Brief Summary

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.

Conditions

  • Ulcerative Colitis (UC)
  • Pouchitis

Intervention / Treatment

  • Drug: 5-ASA
  • Drug: Placebo

Primary Outcome Measures

  • Any event of pouchitis at two years follow up defined as a Pouchitis Disease Activity Index (PDAI) of ≥7. (Within two years of functioning restorative proctocolectomy)
    Pouchitis Disease Activity Index runs from 0-18, where 0 is no symptoms and 18 worst possible symptoms. In case of pouchitis the severity will be graded according to Endoscopic Pouch Score (EPS). 1. Compare time to first event of pouchitis between 5-ASA and placebo prophylaxis. 2. Number of patients having had pouchitis at 3 months, 6 months, 1 and 2 years from having afunctioning pelvic pouch (closure of stoma if diverted at time of pouch creation). 3. Compare response rates of antibiotics and advanced therapy, respectively, in patients developing pouchitis after 5-ASA prophylaxis and placebo. 4. Assess patient satisfaction, health related quality of life (HRQoL), and bowel function and in relation to treatment strategy using questionnaires (Short Health Scale, SF36, Öresland score). 5. Assessment of mucosal permeability (by using an Ussing chamber)

Countries

Sweden

Locations and Investigators

  • Linköping University Hospital, Linköping, Sweden