Pouchitis
Conditions
Brief summary
Change in the pouchitis disease activity index (PDAI
Detailed description
Change in the clinical, endoscopic or histological PDAI, Change in median WBC, CRP, creatinine and liver enzymes from before application of the study drug to 7 days after application of the study drug, Change in microbial diversity in the pouch using 16S rRNA sequencing from before application of the study drug to 7 days after application of the study drug, Safety: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch, Assess the modulation of dendritic cells and inflammatory mechanisms using Nanostring nCounter analysis through mRNA expression and flow cytometry
Interventions
Sponsors
Region Sjaelland, Reponex Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the pouchitis disease activity index (PDAI | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the clinical, endoscopic or histological PDAI, Change in median WBC, CRP, creatinine and liver enzymes from before application of the study drug to 7 days after application of the study drug, Change in microbial diversity in the pouch using 16S rRNA sequencing from before application of the study drug to 7 days after application of the study drug, Safety: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch, Assess the modulation of dendritic cells and inflammatory mechanisms using Nanostring nCounter analysis through mRNA expression and flow cytometry | — |
Countries
Denmark
Outcome results
None listed