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

NCT04979832 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-01-26

No results posted yet for this study

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.

Conditions

  • Pouchitis

Interventions

DRUG

GM-CSF, fosfomycin and metronidazole

GM-CSF 50 micrograms Fosfomycin 400 milligrams Metronidazole 100 milligrams applied as a gel in the pouch

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Ismail Gögenur, Professor · Zealand University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04979832 on ClinicalTrials.gov