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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 February 2023
• Main ID: NCT04979832
• Date of registration: 30/06/2021
• Prospective Registration: Yes
• Primary sponsor: Zealand University Hospital
• Public title: GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery
• Scientific title: A Combined Treatment With GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative Ileal Pouch Anal Anastomosis Surgery
• Date of first enrolment: September 6, 2021
• Target sample size: 18
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04979832
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Denmark

Contacts

• Name: Viviane Lin, MD

• Name: Viviane Lin, MD

• Name: Ismail Gögenur, Professor
• Affiliation: Zealand University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pouchitis

Intervention(s)

Drug: GM-CSF, fosfomycin and metronidazole

Primary Outcome(s)

Phase 2: Proof of concept study, Change in the pouchitis disease activity index (PDAI) [Time Frame: 14 days after first application of the study drug]

Phase 1: safety study, Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch [Time Frame: 30 days after first application of study drug]

Secondary Outcome(s)

Phase 1: Change in the pouchitis disease activity index (PDAI) [Time Frame: Within 7 days after application of the study drug]

Phase 1: Number of trial participants with a change in median CRP after treatment [Time Frame: Within 7 days after application of the study drug]

Phase 1: Number of trial participants with a change in median white blood cells after treatment [Time Frame: Within 7 days after application of the study drug]

Phase 2: Change in the clinical, endoscopic or histological PDAI [Time Frame: 14 days after first application of the study drug]

Phase 2: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch [Time Frame: 37 days after first application of the study drug]

Phase 1: Change in microbial diversity in the pouch using 16S rRNA sequencing [Time Frame: Within 7 days after application of the study drug]

Phase 1: Number of trial participants with a change in median creatinine after treatment [Time Frame: Within 7 days after application of the study drug]

Phase 2: Number of trial participants with a change in median creatinine after treatment [Time Frame: 14 days after first application of the study drug]

Phase 2: Number of trial participants with a change in median liver enzymes after treatment [Time Frame: 14 days after first application of the study drug]

Phase 2: Change in microbial diversity in the pouch using 16S rRNA sequencing [Time Frame: 14 days after first application of the study drug]

Phase 1: Number of trial participants with a change in median liver enzymes after treatment [Time Frame: Within 7 days after application of the study drug]

Phase 2: Number of trial participants with a change in median CRP after treatment [Time Frame: 14 days after first application of the study drug]

Phase 2: Number of trial participants with a change in median white blood cells after treatment [Time Frame: 14 days after first application of the study drug]

Secondary ID(s)

REG-106-2020

2020-000609-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors