GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Pouchitis
Interventions
DRUG

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."

OTHER

Diet

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.

Trial Locations (1)

3000

university hospitals Leuven, Leuven

All Listed Sponsors
lead

Universitaire Ziekenhuizen KU Leuven

OTHER