drugset / Trial / NCT04979832
GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-09-06
- Primary completion
- 2023-12
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosfomycin | Small molecule | 400 mg | Other |
| Subject | Metronidazole | Small molecule | 100 mg | Other |
| Subject | sargramostim | Protein / enzyme biologic | 50 ug | Other |