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Ongoing Clinical Trials for Gastrointestinal Disorders

Currently, there are 8 ongoing clinical trials investigating treatments for various gastrointestinal disorders, including Crohn’s disease, ulcerative colitis, systemic sclerosis with gastrointestinal involvement, and intestinal failure-associated liver disease. These trials are being conducted across 19 countries in Europe, testing medications ranging from established treatments to experimental therapies.

Clinical trial locations

Study of Hydroxychloroquine Safety and Effectiveness in Patients with Early Systemic Sclerosis

This trial is investigating whether hydroxychloroquine can benefit patients with early-stage systemic sclerosis, a condition that causes hardening of the skin and internal organs due to an overactive immune system. The study is being conducted in Italy and focuses on patients who have been diagnosed within the past five years.

Inclusion criteria: To participate, patients must be adults aged 18 or older with confirmed systemic sclerosis diagnosed within five years, counting from the first symptom other than circulation problems in the fingers and toes. Participants must have been on stable treatment for at least four weeks before joining the study and either never taken hydroxychloroquine before or stopped taking it at least 16 weeks prior to enrollment.

Exclusion criteria: The study excludes individuals under 18 or over 65 years old, those with known allergies to hydroxychloroquine, pregnant or breastfeeding women, and patients with significant heart, kidney, or liver problems. People with eye problems affecting the retina, severe blood disorders, uncontrolled diabetes, active infections, history of seizures, or those participating in other clinical trials are also excluded.

Treatment approach: Participants will receive either hydroxychloroquine tablets or a placebo while continuing their standard treatments. The hydroxychloroquine dose is calculated based on body weight, up to a maximum of 400 mg per day, taken orally for 52 weeks. Doctors will monitor various aspects of the disease including skin changes, blood vessel function, pain levels, morning stiffness, and fatigue throughout the year-long study.

Investigational drugs: The trial uses hydroxychloroquine, a medication commonly prescribed for malaria and autoimmune conditions. It works by reducing inflammation and modifying immune system function, taken in tablet form by mouth.

Study on Mesalazine for Patients with Mild to Moderate Ulcerative Colitis

This double-blind trial is evaluating mesalazine for patients with mild to moderate ulcerative colitis, a condition causing inflammation and sores in the large intestine lining. The study is taking place across seven European countries: Poland, Slovakia, Czechia, Hungary, Bulgaria, France, and Spain.

Inclusion criteria: Participants must be at least 18 years old with symptoms of ulcerative colitis for at least three months and inflammation confirmed by medical tests. The disease must be active and mild to moderate at screening, with specific symptom scores. Patients may be new to treatment or currently taking oral mesalazine up to 2.5 g daily or rectal mesalazine up to 1 g daily. Women of childbearing potential must agree to pregnancy testing and effective contraception throughout the study.

Exclusion criteria: The study excludes patients with other serious health conditions that could interfere with the study, those currently in another clinical trial, recent surgery patients, pregnant or breastfeeding women, people with medication allergies, those who have used certain interfering medications, individuals with drug or alcohol abuse history, those with infections requiring antibiotics, and patients with cancer history except certain skin cancers.

Treatment approach: Participants will receive either mesalazine or placebo orally for eight weeks in a double-blind manner. The study monitors symptom reduction including stool frequency and rectal bleeding, as well as improvements seen during endoscopy examinations. Regular assessments track the medication’s safety and any side effects.

Investigational drugs: Mesalazine is an aminosalicylate medication that reduces inflammation in the colon by inhibiting certain inflammatory chemicals in the body. The goal is to achieve clinical remission and improve quality of life for patients with ulcerative colitis.

Study on the Effectiveness of Budesonide and Omeprazole for Treating Crohn’s Disease in the Esophagus, Stomach, or Duodenum in Children

This Polish trial is examining a treatment approach for children with inflammation in the upper digestive tract caused by Crohn’s disease. The study focuses on children aged 6 to 18 years with confirmed inflammation affecting the esophagus, stomach, or duodenum.

Inclusion criteria: Children between 6 and 18 years old must have a confirmed diagnosis of Crohn’s disease based on clinical symptoms, endoscopic examination, and tissue analysis. Inflammatory changes in the esophagus, stomach, or duodenum must be confirmed through both endoscopy and histopathological examination. The child’s treatment must have been stable for at least two weeks, and other causes of inflammation must be ruled out. Parental consent is required, along with consent from children 16 years or older. Sexual abstinence must be declared throughout the study.

Exclusion criteria: Children without confirmed Crohn’s disease, those outside the specified age range, patients with other interfering medical conditions, those unable to follow study procedures, participants in other trials, recent surgery patients, and pregnant or breastfeeding individuals cannot join the study.

Treatment approach: Participants receive budesonide as a nebulizer suspension taken orally at 0.50 mg/ml concentration, along with omeprazole gastro-resistant capsules at 10 mg. Regular monitoring through endoscopic and histopathological evaluations occurs at specified intervals to assess treatment effectiveness. The Pediatric Crohn Disease Activity Index measures disease activity, and a Visual Analogue Scale assesses treatment tolerance.

Investigational drugs: Budesonide is a glucocorticoid medication applied topically to reduce inflammation in the affected digestive tract areas. Omeprazole is a proton pump inhibitor that reduces stomach acid production to support the treatment process.

Study on the Safety and Effects of Orziloben (NST-6179) for Patients with Intestinal Failure-Associated Liver Disease

This experimental Phase 2a trial is investigating Orziloben, a new oral medication for intestinal failure-associated liver disease, a condition affecting the liver in people who depend on nutrition delivered through a vein. The study is being conducted in Belgium, France, and Denmark.

Inclusion criteria: Participants must be 18 years or older, agree to appropriate contraception methods, and sign informed consent. They need a negative COVID-19 test within three days before starting the study. Patients must have been on parenteral nutrition for at least six months with a stable regimen for four weeks prior to and during screening. A confirmed diagnosis of intestinal failure-associated liver disease based on elevated liver enzymes for at least six months is required. Participants must maintain consistent physical activity, diet, and lifestyle throughout the study.

Exclusion criteria: The study excludes patients outside the specified age range, those unable to take oral medication, individuals with interfering medical conditions, pregnant or breastfeeding women, recent participants in other trials, people with medication allergies, those with substance abuse or alcohol dependency history, and patients unable to comply with study procedures.

Treatment approach: The study has two parts. Part A involves four weeks of multiple oral doses of Orziloben with monitoring for side effects and how the body processes the medication. Part B extends treatment to twelve weeks with continued monitoring of safety, tolerability, and effects on liver health markers, inflammation, fat buildup, and metabolism of fats, sugars, and bile acids.

Investigational drugs: Orziloben is an experimental oral medication being studied for its potential to help manage liver disease associated with intestinal failure by affecting liver fat, inflammation, and bile acid metabolism, though its exact mechanism is still under investigation.

Study Comparing FOLFIRI with Cetuximab or Bevacizumab for First-Line Treatment in Patients with Metastatic Colorectal Cancer and Specific Genetic Profiles

This Italian trial is comparing two treatment combinations for patients with metastatic colorectal cancer that has spread to other parts of the body. The study specifically focuses on patients whose cancer has certain genetic characteristics detected through tissue and liquid biopsy testing.

Inclusion criteria: Participants must be over 18 years old with written consent to participate. Women of childbearing potential need a negative pregnancy test within 24 hours before treatment and must use effective contraception during the trial and for five months afterward. Men with female partners must use contraception for seven months after the last treatment. Patients must have confirmed colorectal adenocarcinoma with specific genetic markers, metastatic disease that cannot be surgically removed, no previous chemotherapy for metastatic disease, life expectancy over three months, measurable cancer areas, good general health status, and adequate bone marrow, liver, and kidney function.

Exclusion criteria: The study excludes patients who have received treatment for advanced or metastatic disease, those not suitable for first-line therapy with the study medications, patients with different diagnoses, those without the specific genetic markers being studied, and vulnerable populations unable to give consent.

Treatment approach: One group receives FOLFIRI chemotherapy (folinic acid, fluorouracil, and irinotecan) combined with cetuximab, while the other receives FOLFIRI with bevacizumab. The medications are administered through intravenous infusion for up to eight months. Regular monitoring assesses disease progression, treatment response, overall survival rates, and safety.

Investigational drugs: FOLFIRI is a combination chemotherapy that interferes with cancer cell growth. Cetuximab is a targeted therapy blocking a protein on cancer cell surfaces to slow growth. Bevacizumab inhibits blood vessel growth that tumors need to grow and spread.

Study on the Effects and Safety of Fecal Microbiota Transplant in Children with Autism and Digestive Issues

This French trial is investigating whether fecal microbiota transplantation can help children with autism spectrum disorder who also experience digestive problems. The study uses an enema containing healthy bacteria from donors to introduce beneficial microorganisms into the child’s digestive system.

Inclusion criteria: Children must be between 36 and 72 months old (3 to 6 years) with an autism spectrum disorder diagnosis based on established criteria. They must have experienced gastrointestinal symptoms such as diarrhea, abdominal pain, constipation, indigestion, or reflux for over a year, with a symptom score of 5 or more. Consent from all legal guardians is required, and the child must be covered by social insurance.

Exclusion criteria: Children outside the age range, those without autism spectrum disorder, patients with other interfering medical conditions, those unable to follow study procedures, recent participants in other trials, children who have had previous fecal microbiota transplantation, those with severe allergies or medication reactions, patients taking interfering medications, children with certain gastrointestinal diseases, and those with compromised immune systems are excluded.

Treatment approach: The treatment involves administering an enema containing allogeneic fecal microbiota (healthy bacteria from a donor) rectally over a maximum of 14 days. Parents evaluate gastrointestinal symptoms using rating scales at the start, week 4, week 18, week 24, and month 12. The study monitors for side effects, improvements in digestive symptoms, changes in autism core symptoms, and quality of life throughout the follow-up period.

Investigational drugs: Fecal microbiota transplantation is a microbiome-based therapy involving the transfer of healthy bacteria from donor stool to help balance gut bacteria and potentially improve both digestive symptoms and overall well-being in children with autism.

Study Comparing Risankizumab and Ustekinumab for Adults with Moderate to Severe Crohn’s Disease After Anti-TNF Therapy Failure

This large international trial is comparing two biologic medications for adults with moderate to severe Crohn’s disease who have not responded well to previous anti-TNF therapies. The study is being conducted across 14 European countries including France, Belgium, Austria, Spain, Romania, Greece, Italy, Hungary, Germany, Bulgaria, Slovakia, Netherlands, Poland, and Czechia.

Inclusion criteria: Participants must be between 18 and 80 years old with confirmed Crohn’s disease for at least three months. They must have a disease activity score between 220 and 450 at the study start, based on symptoms like stool frequency and abdominal pain, along with endoscopy results. Patients must have shown intolerance or inadequate response to one or more anti-TNF therapies. Women of childbearing potential must follow contraception recommendations.

Exclusion criteria: The study excludes patients without Crohn’s disease diagnosis, those who haven’t failed anti-TNF therapy, individuals under 18 years old, patients who haven’t completed the Week 48 visit in Part 1 (for Part 2 participation), those unable to comply with study requirements or follow-up visits, and patients with other medical conditions that would make participation unsafe.

Treatment approach: The study has two parts. Part 1 involves 48 weeks of treatment with either risankizumab or ustekinumab, administered as injections or infusions. Part 2 focuses on long-term safety of risankizumab for up to 220 weeks. A Continuous Treatment Extension ensures ongoing care with risankizumab until commercial availability. Regular monitoring assesses clinical remission, endoscopic remission, symptom reduction, and steroid-free maintenance of remission.

Investigational drugs: Risankizumab is a monoclonal antibody that targets interleukin-23, helping reduce inflammation in the gut. Ustekinumab blocks interleukin-12 and interleukin-23, decreasing inflammation and alleviating symptoms. Both are biologic therapies aimed at controlling inflammation in Crohn’s disease.

Study on the Effectiveness and Safety of Guselkumab and Golimumab for Patients with Moderate to Severe Crohn’s Disease

This extensive trial is investigating combination therapy using guselkumab and golimumab for moderate to severe Crohn’s disease. The study spans 19 European countries including Croatia, Poland, Germany, Denmark, Italy, Hungary, Czechia, Estonia, Austria, Netherlands, Spain, France, Norway, Sweden, Portugal, Greece, Bulgaria, Belgium, and Slovenia.

Inclusion criteria: Participants must have been diagnosed with Crohn’s disease for at least three months with confirmed moderate to severe disease activity. The diagnosis is determined by specific disease activity scores measuring stool frequency, abdominal pain, and endoscopic exam results. Patients must have shown inadequate response, lost response, or been intolerant to at least one advanced therapy for inflammatory bowel disease, including biologics or similar oral medications. Women of childbearing potential must follow specific contraception and reproduction requirements.

Exclusion criteria: The study excludes patients without Crohn’s disease diagnosis, those who haven’t failed anti-TNF therapy, non-adults, patients unable to comply with study requirements or follow-up visits, and individuals with other medical conditions that would make participation unsafe.

Treatment approach: Participants receive either combination therapy with guselkumab and golimumab, one of the medications alone, or placebo through subcutaneous injections for approximately 48 weeks. The study includes an initial treatment phase followed by a maintenance phase to evaluate long-term effectiveness and safety. Regular clinical evaluations and endoscopic assessments monitor for remission, with results compared between treatment groups.

Investigational drugs: Guselkumab is a monoclonal antibody targeting interleukin-23, while golimumab is a TNF inhibitor that blocks tumor necrosis factor-alpha. Both work to reduce inflammation and immune system activity. The trial also includes JNJ-78934804, an investigational combination therapy being tested to determine if it provides better results than using each medication individually.

Summary

The current landscape of clinical trials for gastrointestinal disorders shows several important patterns. Crohn’s disease represents the most studied condition, with five trials investigating various treatment approaches from pediatric upper gastrointestinal inflammation to adult moderate-to-severe disease. These trials are testing both established biologics and novel combination therapies, reflecting ongoing efforts to find more effective treatments for patients who have not responded to standard therapies.

Geographically, the trials show strong representation across Europe, with France participating in five trials, followed by Italy, Poland, and Spain with four each. Several large multinational studies span across numerous countries, particularly those investigating biologic therapies for Crohn’s disease, suggesting coordinated European efforts to advance treatment options.

The range of investigational approaches is diverse, from traditional anti-inflammatory medications like mesalazine for ulcerative colitis to innovative therapies such as fecal microbiota transplantation for children with autism and digestive issues. Multiple trials are comparing different biologic medications, including risankizumab, ustekinumab, guselkumab, and golimumab, indicating active research into determining which treatments work best for specific patient populations.

Notably, several trials focus on patients who have failed previous treatments, particularly anti-TNF therapies, highlighting the medical need for alternative treatment options. The studies also demonstrate attention to pediatric populations, rare conditions like intestinal failure-associated liver disease, and systemic conditions with gastrointestinal involvement such as systemic sclerosis.

Ongoing Clinical Trials on Gastrointestinal disorder

  • Study on the Safety and Effects of Orziloben (NST-6179) for Patients with Intestinal Failure-Associated Liver Disease

    Not yet recruiting

    2 1
    Investigated diseases:
    Belgium Denmark France

  • Study on the Effects and Safety of Fecal Microbiota Transplant in Children with Autism and Digestive Issues

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France

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