ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Phase 4 · Testing 5-ASA · 1 site · University Hospital, Linkoeping
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing 5-ASA (a drug) to see if it can prevent disease or complications. Condition(s) listed: Ulcerative Colitis (UC) and Pouchitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 110 participants are expected to take part.
- Start date: 2027-04-01 (planned).
- Main results expected around 2031-03-31 (estimate from the record).
- 1 study site listed in Sweden.
Main thing being measured
- 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)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Pouchitis |
| 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 |
| Enrollment | 110 (estimated) |
| Start date | 2027-04-01 |
| Primary completion (est.) | 2031-03-31 |
| First posted | 2026-08-19 |
| Last updated | 2026-08-19 |
| 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 |
| ClinicalTrials.gov ID | NCT07773948 |
Interventions
- 5-ASA (Drug)
Topical prophylactic treatment of pouchitis after restorative proctocolectomy - Placebo (Drug)
Topical placebor after restorative påroctocolectomy
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * Patients with concomitant primary sclerosing cholangitis (PSC) or previous intolerance to 5-ASA will be excluded.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Linköping University Hospital | Linköping | Sweden |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.