A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch. MedDRA version: 20.0 Level: PT Classification code 10036463 Term: Pouchitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Repomol
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Molgramostim
CAS Number: 99283-10-0
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Co
Sponsors
Center for Surgical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients • 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 as mentioned below (until day 30 in Phase I and until day 37 in Phase II). In men, there is no evidence of GM-CSF or the administered antibiotics increasing risk for genetic damages in the spermatozoa that can result in embryopathies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. A pregnancy test (serum Hcg) must be negative before inclusion into the trial. • Patients with ASA IV classification (American Society of Anesthesiologists physical status classification) • Patients with severe pulmonary disease • Patients with autoimmune thrombocytopenia • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: Safety: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch. Phase 2: Change in the pouchitis disease activity index (PDAI) – A decrease of 3 points or more will be determined as an improvement in PDAI from before application of the study drug to 7 days after application of the study drug ;Secondary Objective: Phase 1: • Change in the pouchitis disease activity index (PDAI) • Change in median WBC, CRP, creatinine and liver enzymes • Change in microbial diversity in the pouch using 16S rRNA sequencing Phase 2: • Change in the clinical, endoscopic or histological PDAI • Change in median WBC, CRP, creatinine and liver enzymes • Change in microbial diversity in the pouch using 16S rRNA sequencing • Safety: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin.;Primary end point(s): Phase 1: Safety and adverse reactions Phase 2: Change in PDAI Index of 3 or more;Timepoint(s) of evaluation of this end point: 7 days after treatment compared to the baseline test at Day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in microbial diversity after treatment. Significant change in WBC, CRP, liver enzymes Incidence of (serious) adverse events;Timepoint(s) of evaluation of this end point: Clinical chemistry and microbiology: 7 Days after treatment compared to the baseline test at Day 0 Adverse events: up to 30 days after treatment | — |
Countries
Denmark
Contacts
Public ContactClinical Trials Information
Center for Surgical Science
Outcome results
None listed