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Study identifier: NCT06916390 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Condition: Pouchitis  ·  Sponsor: Universitaire Ziekenhuizen KU Leuven

PhasePhase 4
Planned participants20
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Restorative proctocolectomy (RPC) with ileal pouch-anal anastomosis (IPAA) is considered the procedure of choice in patients with ulcerative colitis (UC) refractory to medical therapy or with neoplasia. The most common complication after IPAA is the development of pouchitis. Pouchitis is clinically characterized by variable symptoms including increased stool frequency, altered consistency, bloody stools, abdominal cramping, urgency, and incontinence. Symptomatic pouchitis longer than four weeks is considered chronic pouchitis. The conventional treatment for acute and chronic pouchitis is antibiotics, such as metronidazole and ciprofloxacin. The disease course of antibiotic responsive pouchitis may evolve into antibiotic dependent (requiring antibiotic maintenance therapy) pouchitis and then antibiotic refractory (no response to antibiotic treatment) pouchitis. Although many patients respond to antibiotic therapy, there is also evidence that suggest that aberrant regulation of the mucosal immune system might play a part in the pathogenesis of pouchitis arising from an abnormal mucosal immune response to a dysbiosis of the pouch microbiota. If individuals fail to respond to antibiotics, anti-tumor necrosis factor (anti-TNF) agents and vedolizumab have been proposed for the treatment of chronic pouchitis. Guselkumab, an interleukin-23 (IL-23) p19 subunit antagonist monoclonal antibody, is proven to be efficacious in patients with moderately-to-severely active UC. Efficacy of g…

This description comes directly from the study's public registry record.

Talk to the study team

Joao Sabino, Prof Dr  ·  +32  ·  joao.sabino@uzleuven.be

Always discuss trial participation with your own doctor first.

Locations (1)

university hospitals LeuvenLeuven, Vlaams-Brabant, BelgiumRecruiting

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Source record: clinicaltrials.gov/study/NCT06916390