Actively Recruiting
GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
20
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 guselkumab in treating UC has been shown in multiple large clinical trials. However, patients with pouchitis were never the targeted population and were even often excluded from the trials. Pouchitis becomes a chronic problem with a huge impact in the quality of life of these patients. The incidence of pouchitis has been rising in the last decades. This increase might be explained by a change in dietary habits of this population. This open label single center trial at UZ Leuven aims to evaluate the efficacy and safety of guselkumab in the treatment of chronic antibiotic refractory pouchitis during a 48-week treatment period, with or without a dietary intervention. Twenty subjects with a proctocolectomy and IPAA for UC who have developed chronic or relapsing pouchitis will be enrolled.
CONDITIONS
Official Title
GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent given before screening
- At least 18 years of age at consent
- Use of highly effective birth control methods if applicable
- Proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis and chronic or relapsing pouchitis defined by mPDAI score 65 and endoscopic subscore 62
- Either 62 recurrent pouchitis episodes treated with antibiotics or other prescriptions in the past year, maintenance antibiotic therapy for at least 4 weeks and refractory to it, or prior failure of biologic therapy for pouchitis
- Agreement to take ciprofloxacin or alternative antibiotics during the first 4 weeks of the study
You will not qualify if you...
- Crohn's disease or related pouch complications, irritable pouch syndrome, isolated cuffitis, infectious pouchitis, diverting ostomy, or mechanical pouch problems
- Previous treatment with anti-IL12/23 or anti-IL23 antibodies
- Use of investigational biologics or JAK inhibitors within 30 days before screening
- Active or untreated latent tuberculosis
- Chronic hepatitis B or C infection, HIV infection, or immunodeficiency
- Active severe infections such as sepsis or C. difficile
- Allergies or contraindications to ciprofloxacin or metronidazole
- History or current malignancy except certain treated skin and cervical cancers
- Any condition or lab abnormality that risks safety or protocol compliance
- Prior or concurrent treatments jeopardizing safety or study integrity
- Pregnancy, breastfeeding, or inadequate contraception
- Participation in other interventional trials with investigational products
AI-Screening
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Trial Site Locations
Total: 1 location
1
university hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
J
Joao Sabino, Prof Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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