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

NCT07773948 | Not Yet Recruiting Phase 4

• 1 other identifier: Linkoeping University
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Restorative proctocolectomy; Pelvic pouch

Outcome Measures

Primary Outcomes (1)

• Any event of pouchitis at two years follow up defined as a Pouchitis Disease Activity Index (PDAI) of ≥7.

  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)

  Within two years of functioning restorative proctocolectomy

Study Arms (2)

5-ASA

EXPERIMENTAL

5-ASA suppositories

Drug: 5-ASA

Placebo

PLACEBO COMPARATOR

Placebo suppositories

Drug: Placebo

Interventions

5-ASA DRUG

Topical prophylactic treatment of pouchitis after restorative proctocolectomy

5-ASA

Placebo DRUG

Topical placebor after restorative påroctocolectomy

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with UC who are planned for reconstruction with IPAA. All four Swedish units with a national license to perform restorative surgery in IBD will be recruiting patients.

You may not qualify if:

• Patients with concomitant primary sclerosing cholangitis (PSC) or previous intolerance to 5-ASA will be excluded.

Sponsors & Collaborators

• Skane University Hospital: collaborator
• Region Örebro County: collaborator
• Örebro University, Sweden: collaborator
• Karolinska Institutet: collaborator
• Göteborg University: collaborator
• University Hospital, Linkoeping: lead
• Karolinska University Hospital: collaborator
• Östra Hospital: collaborator
• Lund University: collaborator

Study Sites (1)

Linköping University Hospital

Linköping, 58185, Sweden

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Pouchitis

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Ileitis; Enteritis; Ileal Diseases

Central Study Contacts

Pär Myrelid, Prof, MD, PhD

CONTACT

+46101031581; par.myrelid@liu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)