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

NCT04979832 | Unknown Phase 1 DMC

• 2 other identifiers: REG-106-20202020-000609-10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Phase 1: safety study, Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch

  Incidence of Treatment-Emergent Adverse Events

  30 days after first application of study drug

• Phase 2: Proof of concept study, 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. Between 0-18 points can be given, with a score of 7 or higher indicating pouchitis.

  14 days after first application of the study drug

Secondary Outcomes (13)

• Phase 1: Change in the pouchitis disease activity index (PDAI)

  Within 7 days after application of the study drug

• Phase 1: Number of trial participants with a change in median white blood cells after treatment

  Within 7 days after application of the study drug

• Phase 1: Number of trial participants with a change in median CRP after treatment

  Within 7 days after application of the study drug

• Phase 1: Number of trial participants with a change in median creatinine after treatment

  Within 7 days after application of the study drug

• Phase 1: Number of trial participants with a change in median liver enzymes after treatment

  Within 7 days after application of the study drug

Study Arms (1)

Local administration of GM-CSF, fosfomycin and metronidazole in the pouch

EXPERIMENTAL

Local administration of 50 micrograms GM-CSF, 400 milligrams fosfomycin and 100 milligrams metronidazole in the pouch. In a Phase A of the trial, this will be applied as a single dose during endoscopy of the pouch. In Phase B of the trial, this will be applied as a first dose during endoscopy of the pouch, followed by 6 further daily doses for a total of 7 doses.

Drug: GM-CSF, fosfomycin and metronidazole

Interventions

GM-CSF, fosfomycin and metronidazole DRUG

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

Also known as: GM-CSF, Fosfomycin, Metronidazole

Local administration of GM-CSF, fosfomycin and metronidazole in the pouch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (until day 30 in Phase I and until day 37 in Phase II), such as implants, injectables, oral contraceptives, IUD (intrauterine device), sexual abstinence or vasectomized partner.

You may not qualify if:

• 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
• Patients with ASA IV classification (American Society of Anesthesiologists physical status classification)
• Patients with severe pulmonary disease
• Patients with autoimmune thrombocytopenia
• Patients with severe renal impairment (eGFR \< 40 ml/min)
• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

RECRUITING

MeSH Terms

Conditions

Pouchitis

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Fosfomycin; Metronidazole

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ismail Gögenur, Professor

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviane Lin, MD

CONTACT

60547025; vial@regionsjaelland.dk

Ismail Gögenur, Professor

CONTACT

26356426; igo@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 28, 2021
• Study Start: September 6, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)