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 range18 Years
SexALL
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 anticā¦
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