RecruitingRare disease

Study on GM-CSF, Fosfomycin, and Metronidazole for Treating Pouchitis in Ulcerative Colitis Patients Post-Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called pouchitis, which can occur in patients who have had surgery for ulcerative colitis. The surgery, known as restorative ileal pouch anal anastomosis, is a procedure where a pouch is created from the small intestine to help with bowel movements. Pouchitis is an inflammation of this pouch, and it can cause symptoms similar to those of Crohn's disease. The study aims to explore a new treatment approach using a combination of three medications: GM-CSF (also known as molgramostim), fosfomycin, and metronidazole. These medications will be applied directly to the pouch to see if they can help manage the condition by targeting bacterial imbalance and improving the immune response.

Participants in the study will receive the treatment over a specific period, and their health will be monitored to assess the safety and effectiveness of the treatment. The study will look at changes in the severity of pouchitis symptoms and other health indicators, such as white blood cell counts and liver enzymes, before and after the treatment. Researchers will also examine the diversity of bacteria in the pouch to understand how the treatment affects the microbial environment.

The study is designed to gather important information about the potential benefits and risks of this combined treatment for pouchitis. By participating, researchers hope to learn more about how these medications can be used to help patients with this condition, potentially leading to better treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, previous diagnosis of ulcerative colitis, and having undergone specific surgery.
Understanding and ability to complete study procedures are assessed.
Step 2
Treatment phase
The treatment involves a combination of three medications: metronidazole, fosfomycin, and molgramostim.
These medications are applied directly in the pouch, which is the area affected by pouchitis.
The aim is to address bacterial imbalance and immune response issues associated with pouchitis.
Step 3
Monitoring and assessment
The primary focus is on changes in the pouchitis disease activity index (PDAI), which measures the severity of the condition.
Secondary assessments include changes in clinical, endoscopic, or histological PDAI, and various blood markers such as white blood cells and liver enzymes.
Microbial diversity in the pouch is also evaluated using specific sequencing techniques.
Step 4
Safety evaluation
Safety is monitored by identifying any serious or non-serious adverse reactions to the medications.
The study also examines the modulation of immune cells and inflammatory mechanisms using advanced analysis techniques.
Step 5
Completion of study
The study is expected to conclude by August 2027.
Participants are required to use effective contraception methods for the duration of the trial, extending slightly beyond the treatment phase.

Who can join the trial?

9 criteria

Be of any gender.
Be over 18 years of age.
Have a previous diagnosis of **ulcerative colitis** (a condition that causes inflammation and sores in the colon and rectum).
Have had **IPAA surgery** (a surgery to create a pouch from the small intestine after removing the colon and rectum).
Have been diagnosed with **pouchitis** (inflammation of the pouch created during IPAA surgery).
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, such as implants, injectables, oral contraceptives, **IUD** (intrauterine device), sexual abstinence, or having a vasectomized partner.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with pouchitis cannot participate. Pouchitis is a condition that affects the lining of a surgically created pouch in the intestines.
Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
Participants who are part of a vulnerable population, such as those who cannot give informed consent, are not eligible.
Both males and females can participate, but those who do not meet the gender criteria are excluded.

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Region Sjaelland
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Holbæk, Denmark

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Investigated drugs

GM-CSF
is a medication used in this trial to help boost the immune system. It is applied directly to the affected area in the pouch. The goal is to improve the body's ability to fight off infections and inflammation associated with pouchitis, a condition that can occur after certain surgeries for ulcerative colitis.
Fosfomycin
is an antibiotic used in this trial to help reduce harmful bacteria in the pouch. By targeting bacterial dysbiosis, it aims to restore a healthier balance of bacteria, which may help alleviate symptoms of pouchitis.
Metronidazole
is another antibiotic included in the trial. It is used to treat infections caused by bacteria and certain parasites. In this study, it is applied to the pouch to help control bacterial growth and reduce inflammation, working alongside fosfomycin to improve the condition of patients with pouchitis.

What is already known about the treatment

GM-CSF
This medication is administered topically in the pouch and is currently being studied for its potential use in treating pouchitis, a condition that can occur after surgery for ulcerative colitis. GM-CSF is known to stimulate the immune system by promoting the growth of white blood cells, which may help in managing the immune response in pouchitis. It is classified as an immunomodulator and is being investigated for its ability to address the inadequate immune response associated with this condition.
Fosfomycin
Fosfomycin is applied topically in the pouch and is being evaluated for its effectiveness in treating pouchitis. It is an antibiotic that works by inhibiting bacterial cell wall synthesis, which helps in reducing bacterial overgrowth and dysbiosis in the pouch. Fosfomycin is classified as an antibacterial agent and is being studied for its role in managing bacterial infections in pouchitis.
Metronidazole
This medication is also administered topically in the pouch and is under investigation for its use in treating pouchitis. Metronidazole is an antibiotic that works by disrupting the DNA of bacteria, leading to their death. It is classified as an antimicrobial agent and is being explored for its potential to control bacterial infections and inflammation in pouchitis.

Investigated diseases

Pouchitis – Pouchitis is an inflammation of the ileal pouch, which is created during surgery for ulcerative colitis. This condition often occurs after the surgical removal of the colon and rectum, where the small intestine is used to form a pouch to store waste. Symptoms typically include increased stool frequency, abdominal pain, and sometimes fever. The inflammation can lead to discomfort and urgency in bowel movements. Pouchitis may mimic some aspects of Crohn's disease, particularly in its inflammatory response. The exact cause is not fully understood, but it is believed to involve bacterial imbalance and immune system factors.