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Guselkumab intervention and diet evaluation for pouchitis
EU CTIS ID: 2025-521683-35-00
What this study is testing
To describe the efficacy of guselkumab and the efficacy of the combination of guselkumab and a dietary intervention in improving the symptoms of patients with relapsing or refractory pouchitis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Fluent in reading and speaking Dutch
- Participants must be at least 18 years of age and younger than 80 years of age at the time of signing the Informed Consent Form (ICF)
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner
- The subject agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study. For patients who did previously not tolerate quinolone therapy, an alternative antibiotic therapy between Day 1 and Week 4 with metronidazole (500 mg three times a day) will be allowed. (Additional courses of antibiotics will be allowed, as needed, for flares after Week 16.)
- Participant with a proctocolectomy and IPAA for UC who developed chronic or recurrent pouchitis, defined as mPDAI score ≥5 and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either: (a) ≥2 recurrent episodes within 1 year prior to the screening visit, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) patients treated with maintenance antibiotic therapy taken continuously for four consecutive weeks before the screening visit and who are refractory to this antibiotic therapy, or (c) previously failure of another biologic therapy to treat chronic pouchitis.
You likely can't join if
- Crohn’s disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectious pouchitis, diverting ostomy or mechanical complications of the pouch
- Chronic hepatitis B virus (HBV)* infection, chronic hepatitis C virus (HCV)** infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient (e.g., due to organtransplantation, history of common variable immunodeficiency, etc). * Subjects who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For subjects who are negative for HBsAg but are positive for either surface antibodiesand/or core antibodies, HBV DNA polymerase chain reaction will be performed and if anytest result meets or exceeds detection sensitivity, the subject will be excluded.** If subject is HCV antibody positive, then a viral load test will be performed. If the viralload test is positive then the subject will be excluded.
- Active severe infection (eg sepsis, cytomegalovirus, listeriosis or C. difficile)
- The subject has allergies to and/or contraindications for ciprofloxacin and metronidazole
- Participant has a history of malignancy or current malignancy, except for the following: adequately treated non-metastatic basal cell skin cancer, squamous cell skin cancer and cervical carcinoma in situ. Subjects with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy
- Participant has serious hypersensitivity to guselkumab or to any of its excipients.
See the full eligibility criteria
Who can join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Fluent in reading and speaking Dutch
- Participants must be at least 18 years of age and younger than 80 years of age at the time of signing the Informed Consent Form (ICF)
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner
- The subject agrees to take ciprofloxacin (500 mg twice daily) on Day 1 and through Week 4, regardless of the previous treatment and to stop any previous antibiotic therapy on Day 1 of the study. For patients who did previously not tolerate quinolone therapy, an alternative antibiotic therapy between Day 1 and Week 4 with metronidazole (500 mg three times a day) will be allowed. (Additional courses of antibiotics will be allowed, as needed, for flares after Week 16.)
- Participant with a proctocolectomy and IPAA for UC who developed chronic or recurrent pouchitis, defined as mPDAI score ≥5 and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either: (a) ≥2 recurrent episodes within 1 year prior to the screening visit, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) patients treated with maintenance antibiotic therapy taken continuously for four consecutive weeks before the screening visit and who are refractory to this antibiotic therapy, or (c) previously failure of another biologic therapy to treat chronic pouchitis.
What rules you out
- Crohn’s disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectious pouchitis, diverting ostomy or mechanical complications of the pouch
- Chronic hepatitis B virus (HBV)* infection, chronic hepatitis C virus (HCV)** infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient (e.g., due to organtransplantation, history of common variable immunodeficiency, etc). * Subjects who are positive for hepatitis B virus surface antigen (HBsAg) will be excluded. For subjects who are negative for HBsAg but are positive for either surface antibodiesand/or core antibodies, HBV DNA polymerase chain reaction will be performed and if anytest result meets or exceeds detection sensitivity, the subject will be excluded.** If subject is HCV antibody positive, then a viral load test will be performed. If the viralload test is positive then the subject will be excluded.
- Active severe infection (eg sepsis, cytomegalovirus, listeriosis or C. difficile)
- The subject has allergies to and/or contraindications for ciprofloxacin and metronidazole
- Participant has a history of malignancy or current malignancy, except for the following: adequately treated non-metastatic basal cell skin cancer, squamous cell skin cancer and cervical carcinoma in situ. Subjects with a remote history of malignancy (e.g., >10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy
- Participant has serious hypersensitivity to guselkumab or to any of its excipients.
- Any disorder or laboratory abnormalities which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Female who is pregnant, breast-feeding or intends to become pregnant before, during, or within 12 weeks after the last dose of study drug; or intending to donate ova during such time period or is of child-bearing potential and not using an adequate, highly effective contraceptive or males who want to make their partner pregnant or intend to donate sperm during the course of this study or for 12 weeks after the last dose of study drug
- Participation in another interventional Trial with an investigational medicinal product (IMP) or device
- Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
- Any investigational or approved biologic agent within 30 days of screening
- Nonbiologic investigational therapy or JAK inhibitors within 30 days prior to screening
- Active or untreated latent tuberculosis (TB). In case of a newly identified positive diagnostic TB test result (defined as a positive tuberculin skin test) , active TB has to be ruled out and appropriate treatment for latent TB has to be initiated for a minimum of 4 weeks prior to the first administration of study medication
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.