A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patients

Phase 1

• Conditions: 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: 20.0Level: PTClassification code 10036463Term: PouchitisSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-000609-10-DK
• Lead Sponsor: Center for Surgical Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-23
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 26

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified