Ongoing Clinical Trials for Pouchitis
Currently, there are 2 ongoing clinical trials investigating new treatments for pouchitis, a condition that causes inflammation of the surgically created pouch in patients who have had surgery for ulcerative colitis. These trials are testing different medications to help reduce symptoms and improve quality of life for patients, including children and adults.
Clinical trial locations
- Belgium
- Croatia
- Czechia
- Denmark
- Greece
- Italy
- Poland
- Spain
Study on the Effectiveness and Safety of Vedolizumab for Children with Chronic Pouchitis Using a Drug Combination
This study is testing a medication called vedolizumab for children suffering from active chronic pouchitis. Vedolizumab is given through an intravenous infusion, which means it is delivered directly into a vein. The medication works by targeting specific proteins in the body to reduce inflammation in the digestive tract.
Main inclusion criteria:
- Children between 2 and 17 years old
- Weighing at least 10 kilograms
- Have had surgery called proctocolectomy and IPAA at least one year before joining the study
- Have active chronic pouchitis confirmed by symptoms and a special camera test called endoscopy
- Must have had at least one previous episode of pouchitis in the past year that lasted at least 4 weeks and was treated with antibiotics, or cannot tolerate antibiotic treatment
- If sexually active, must agree to use appropriate contraception methods
Main exclusion criteria:
- Patients who have conditions other than active chronic pouchitis
- Those outside the specified age range
- Patients unable to follow study procedures or attend required visits
- Those with other medical conditions or taking medications that might interfere with the study
- Patients who have had recent surgery or medical procedures that might affect the study
- Pregnant or breastfeeding patients
- Those with a history of allergies or reactions to vedolizumab
- Patients already participating in another clinical trial
Focus and goal: The main goal of this study is to evaluate how effective and safe vedolizumab is for children with active chronic pouchitis. Researchers will assess whether the medication helps achieve clinical remission by Week 14, meaning a reduction in symptoms and inflammation. The study will monitor participants’ health throughout the treatment period, looking at changes in symptom scores and other health indicators. Participants will receive regular infusions of vedolizumab and attend check-ups at specified intervals, including assessments at Week 14 and Week 34. The research aims to determine if this treatment can improve the quality of life for children with this condition by reducing symptoms and promoting healing.
Study on GM-CSF, Fosfomycin, and Metronidazole for Treating Pouchitis in Ulcerative Colitis Patients Post-Surgery
This clinical trial is exploring a new treatment approach for adults with pouchitis using a combination of three medications: GM-CSF (also known as molgramostim), fosfomycin, and metronidazole. These medications are applied directly to the pouch to target bacterial imbalance and improve the immune response.
Main inclusion criteria:
- Adults over 18 years of age
- Previous diagnosis of ulcerative colitis
- Have had IPAA surgery, which creates a pouch from the small intestine after removing the colon and rectum
- Been diagnosed with pouchitis
- Able to understand and complete study procedures
- Able to speak either Danish or English
- Willing to use highly effective contraception methods during the trial
Main exclusion criteria:
- Patients not diagnosed with pouchitis
- Individuals outside the specified age range
- Those who are part of a vulnerable population and cannot give informed consent
- Patients who do not meet the gender criteria
Focus and goal: The study aims to assess the safety and effectiveness of this combined treatment approach. GM-CSF helps boost the immune system by promoting the growth of white blood cells, while fosfomycin and metronidazole are antibiotics that work to reduce harmful bacteria and control bacterial growth in the pouch. Researchers will monitor changes in the pouchitis disease activity index, which measures the severity of the condition, as well as various blood markers such as white blood cell counts and liver enzymes. The study will also examine the diversity of bacteria in the pouch using special sequencing techniques to understand how the treatment affects the microbial environment. Safety is monitored by identifying any adverse reactions to the medications. The study is expected to conclude by August 2027.
Summary
The two ongoing clinical trials for pouchitis represent different approaches to treating this challenging condition. One trial focuses specifically on children with chronic pouchitis, testing vedolizumab, a medication that targets inflammation through immune system modulation. This pediatric trial is being conducted across multiple European countries including Croatia, Denmark, Italy, Spain, Belgium, Greece, Poland, and Czechia, indicating a broad international effort to find effective treatments for children with this condition.
The second trial, conducted in Denmark, takes a different approach by testing a combination of three medications applied directly to the affected pouch in adult patients. This study combines an immune system booster with two antibiotics to address both bacterial imbalance and immune response issues.
Both trials reflect the medical community’s ongoing efforts to find better treatment options for pouchitis, which can significantly affect the quality of life of patients who have undergone surgery for ulcerative colitis. The diversity of approaches being tested offers hope for more personalized treatment options in the future.
