GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Treatments: Fosfomycin; Metronidazole; Molgramostim; Sargramostim

Criteria

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 anticipated compliance problems as determined by the investigator