GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorati… (NCT04979832) | Clinical Trial Compass
UnknownPhase 1/2
GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery
Denmark18 participantsStarted 2021-09-06
Plain-language summary
This study will examine whether the application of GM-CSF, fosfomycin and metronidazole locally in the pouch is safe and effective in the treatment of pouchitis for patients with ulcerative colitis, and whether treatment changes the microbiome of the pouch.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Of any gender
* Over 18 years of age
* Have a previous diagnosis of ulcerative colitis
* Have had IPAA surgery, and
* Have been diagnosed with pouchitis
* Be able to understand and complete study procedures as determined by the investigator
* Be able to speak either Danish or English
* Be able to comply with study procedures for the length of the study
* Use a highly effective contraception method for the duration of the trial (until day 30 in Phase I and until day 37 in Phase II), such as implants, injectables, oral contraceptives, IUD (intrauterine device), sexual abstinence or vasectomized partner.
Exclusion Criteria:
* Patients with a previous allergic reaction to GM-CSF, metronidazole or fosfomycin
* Patients who are currently under antibiotic treatment or have received antibiotic treatment within the past 30 days
* Patients currently pregnant or breastfeeding
* Patients with ASA IV classification (American Society of Anesthesiologists physical status classification)
* Patients with severe pulmonary disease
* Patients with autoimmune thrombocytopenia
* Patients with severe renal impairment (eGFR \< 40 ml/min)
* Patients with alcohol use disorder or history of drug abuse
* Patients currently in treatment for any malignant or hematological disease
* Patients with a previous history of cancer will be excluded from the study (except for patients with well-treated and stabile cancer after a control period of more than two years).
* Patients with antic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: safety study, Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch
Timeframe: 30 days after first application of study drug
2
Phase 2: Proof of concept study, Change in the pouchitis disease activity index (PDAI)
Timeframe: 14 days after first application of the study drug