GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06916390
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pouchitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    All patients will receive guselkumab 400 mg intravenous at week 0, week 4, and week 8, followed by subcutaneous guselkumab 200 mg at week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 40, week 44, and week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin 500mg twice daily from randomization through week 4.
  • Diet — OTHER
    Subjects randomized to the group with the dietary intervention will be advised to follow a low-UPF, high-fruit diet. Patients will be instructed to restrict the intake of NOVA 4 food products during the first 16 weeks of the trial, and to increase the intake of fruits (minimum 3 servings per day) during the full trial. Dietary education will be provided by certified IBD dietitians, lists of products to avoid, and week menu's will also be provided to increase dietary adherence. Dietary information will be collected with food records and food frequency questionnaires.

Study Details

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.

Key Dates

Start date
Apr 23, 2026
Status verified
Apr 2026
Primary completion
May 30, 2028
Completion
May 30, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: intervention with guselkumab
    All patients will receive guselkumab 400 mg intravenous at week 0, week 4, and week 8, followed by subcutaneous guselkumab 200 mg at week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 40, week 44, and week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin 500mg twice daily from randomization through week 4.
  • Active Comparator: intervention with guselkumab and diet
    All patients will receive guselkumab 400 mg intravenous at week 0, week 4, and week 8, followed by subcutaneous guselkumab 200 mg at week 12, week 16, week 20, week 24, week 28, week 32, week 36, week 40, week 44, and week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin 500mg twice daily from randomization through week 4. Subjects randomized to the group with the dietary intervention will be advised to follow a low-UPF, high-fruit diet. Patients will be instructed to restrict the intake of NOVA 4 food products during the first 16 weeks of the trial, and to increase the intake of fruits (minimum 3 servings per day) during the full trial. Dietary education will be provided by certified IBD dietitians, lists of products to avoid, and week menu's will also be provided to increase dietary adherence. Dietary information will be collected with food records and food frequency questionnaires.

Primary Outcome Measure

percentage of subjects achieving clinical remission after 16 weeks of treatment with guselkumab with/without diet [ Time Frame: 16 weeks ]

Central Contacts

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