Ongoing Clinical Trials for Irritable Bowel Syndrome
There are currently 7 clinical trials testing new treatments for Irritable Bowel Syndrome across Europe. These studies are exploring various approaches including probiotic therapies, plant-based medications, and innovative microbiota transplantation methods to help manage symptoms such as abdominal pain, bloating, and changes in bowel habits.
Clinical trial locations
- Belgium
- France
- Germany
- Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Dominant or Mixed-Type Irritable Bowel Syndrome
- Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Predominant Irritable Bowel Syndrome
- Study on the Effectiveness of E. coli DSM 17252 for Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
- Poland
- Portugal
- Spain
Study Comparing Ebastine and Mebeverine for Treating Irritable Bowel Syndrome in Adults
This trial is comparing two medications, Ebastine and Mebeverine, for treating Irritable Bowel Syndrome. Participants will take one of these medications orally over a 12-week period.
Inclusion criteria: Participants must be adults between 18 and 65 years of age who meet the Rome IV criteria for non-constipated IBS. They must provide voluntary written consent and have no organic cause for their symptoms such as coeliac disease, lactose intolerance, inflammatory bowel disease, or giardiasis. People with lactose intolerance may join if they have not improved after following a lactose-free diet for 6 weeks.
Exclusion criteria: The trial excludes patients with other significant health conditions, those currently in another clinical trial, patients who have had recent surgery or are planning surgery during the study, pregnant or breastfeeding women, patients with known allergies to the study medications, those unable to comply with study procedures, patients with a history of substance abuse or alcohol dependency, those with severe mental health disorders, patients under 18 years old, and patients with immune system disorders.
Focus: This study aims to determine which medication is more effective in managing symptoms like abdominal pain and bloating, and in improving quality of life. Researchers will monitor participants regularly to assess changes in their symptoms throughout the 12-week treatment period.
Investigational drugs: Ebastine is typically used to treat allergies and is being tested to see if it can improve symptoms by blocking histamine receptors, which may reduce inflammation and discomfort in the gut. Mebeverine is an antispasmodic medication that works by relaxing the muscles in the gut, helping to reduce stomach pain and cramps associated with IBS.
Study of Saccharomyces boulardii CNCM I-745 to treat symptoms in adults with non-constipated Irritable Bowel Syndrome
This study focuses on non-constipated IBS, which can cause stomach pain, bloating, and changes in bowel habits. The trial tests a beneficial yeast called Saccharomyces boulardii CNCM I-745 compared to a placebo over an 8-week period.
Inclusion criteria: Participants must be between 18 and 65 years old and have been diagnosed with IBS, but not the constipation-predominant type. They must have a severity score of 175 or higher on the IBS Symptom Severity Scale, be willing to maintain current eating habits, and able to follow study requirements. Women who can become pregnant must agree to use effective birth control during the study.
Exclusion criteria: The study excludes people with known allergies to yeast or any ingredients in the medication, those currently taking antifungal medications, patients with inflammatory bowel disease or celiac disease, those who have had gastrointestinal surgery in the past 6 months, people with severe constipation, those with active gastrointestinal infections in the past 4 weeks, anyone who has used probiotics within the last 2 weeks, pregnant or breastfeeding women, people participating in other trials, and those with severe mental health conditions.
Focus: The research aims to determine if Saccharomyces boulardii CNCM I-745 can improve overall symptoms when taken over an 8-week period. The study measures changes in abdominal pain, bloating, and overall quality of life, with participants being monitored at regular intervals throughout the 12-week study period.
Investigational drugs: Saccharomyces boulardii CNCM I-745 is a probiotic yeast that helps manage symptoms by supporting gut health. It works by improving gut microbiota balance, strengthening the intestinal barrier, and reducing inflammation in the digestive system.
Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Dominant or Mixed-Type Irritable Bowel Syndrome
This trial studies the effects of MYRRHINIL-INTEST, a coated tablet containing natural ingredients such as myrrh, coffee charcoal, and chamomile flower extract. Participants will take either the treatment or a placebo for up to eight weeks.
Inclusion criteria: Patients must be between 18 and 75 years old, have a confirmed diagnosis of diarrhea-dominant or mixed-type IBS, not have experienced weight loss in the past 6 months, have no night-time symptoms, and have no family history of colon cancer. They must have signed informed consent, agree not to change their lifestyle or diet during the study, and be willing to keep a detailed diary. For those over 55 years old, a colon examination must have been performed in the last 5 years. Women who can become pregnant need a negative pregnancy test.
Exclusion criteria: The trial excludes patients with other serious health conditions, those currently in another clinical trial, people who have had recent surgery or are planning surgery, pregnant or breastfeeding women, those with a history of alcohol or drug abuse, patients unable to follow study procedures, people with allergies to the study medication, patients with certain other digestive disorders, those taking interfering medications, and people with severe mental health issues.
Focus: The study aims to evaluate how effective and safe this treatment is compared to a placebo. Participants keep a diary to record symptoms such as abdominal pain, stool consistency, and frequency of bowel movements. The study tracks changes in symptom severity and quality of life throughout the eight-week treatment period.
Investigational drugs: MYRRHINIL-INTEST is a gastrointestinal agent that works by modulating the gut’s natural processes to reduce symptoms like diarrhea and abdominal discomfort. It contains 100 mg of myrrh, 50 mg of coffee charcoal, and 70 mg of chamomile extract.
Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Predominant Irritable Bowel Syndrome
This trial focuses specifically on diarrhea-predominant IBS and tests the same MYRRHINIL-INTEST medication in a similar study design lasting up to eight weeks.
Inclusion criteria: Patients must be between 18 and 75 years old with a confirmed diagnosis of diarrhea-predominant IBS at the first visit. They must have had at least one watery bowel movement per day on at least 3 days in the last week before the first visit. A pain score greater than 3 points and stool consistency recorded using the Bristol stool form scale are required. For patients older than 55 years, a colonoscopy must have been performed within the last 5 years. Stool samples must show no blood and no infection. A negative pregnancy test is required for those who can become pregnant, and participants must sign informed consent and agree not to change their lifestyle during the study.
Exclusion criteria: Individuals who do not have diarrhea-predominant IBS cannot participate. Participants must be within the specified age range, and those unable to give informed consent are excluded.
Focus: The study evaluates how well MYRRHINIL-INTEST works in reducing symptoms such as frequent diarrhea and abdominal discomfort. Participants maintain daily diaries recording symptoms, and regular visits monitor progress and safety throughout the treatment period.
Investigational drugs: MYRRHINIL-INTEST is administered orally in tablet form and works by modulating gut motility and reducing inflammation in the intestines, though the exact mechanism is still under investigation. It is classified as a gastrointestinal agent.
Study on the Effectiveness of E. coli DSM 17252 for Patients with Diarrhea-Predominant Irritable Bowel Syndrome
This clinical trial tests Symbioflor 2, which contains living bacteria known as Escherichia coli DSM 17252. The treatment will be compared to a placebo over a 26-week period.
Inclusion criteria: Participants must be males or females aged 18 years or older with a diagnosis of IBS according to Rome IV criteria. This includes recurrent abdominal pain on average at least 1 day per week in the last 3 months, with pain related to defecation, changes in bowel movement frequency, or changes in stool form. Symptoms must have been present for the last 3 months and started at least 6 months ago. Participants must have the diarrhea-predominant subtype. A colonoscopy with no important findings is required. Women who can have children must use highly effective birth control. Participants must be willing to avoid significant changes in diet and other IBS medications, able to follow the treatment plan, have sufficient knowledge of German, provide written informed consent, and have internet access.
Exclusion criteria: Patients without an IBS diagnosis, those outside the specified age range, and people who are part of vulnerable populations requiring special protection are excluded.
Focus: The study aims to see how effective Symbioflor 2 is in reducing the frequency and severity of symptoms. It will also assess safety and tolerability. Participants report on symptoms such as abdominal pain and stool consistency using simple scales throughout the 26-week treatment period.
Investigational drugs: Symbioflor 2 is a probiotic containing living E. coli DSM 17252 bacteria, administered orally. It is believed to work by modulating the gut microbiota, helping restore balance in the intestinal environment and alleviating symptoms like frequent and severe diarrhea.
Study on the Effects of GSL-01-001 for Patients with Irritable Bowel Syndrome Type D
This trial studies GSL-01-001, a medication taken orally, for managing symptoms of diarrhea-predominant IBS. The study lasts 14 weeks, including a 2-week screening period followed by 12 weeks of treatment.
Inclusion criteria: Participants must be between 18 and 50 years old, able to follow study rules and complete the study, and understand the study enough to provide informed consent. They must have a Body Mass Index between 18 and 40, a diagnosis of diarrhea-predominant IBS, and an average abdominal pain score of 5.5 or higher. If taking certain medications like antidepressants or sleep aids, the dosage must have been stable for 90 days and remain unchanged during the study. Participants must have stable eating habits for the past 12 weeks. Female participants must be post-menopausal, sterilized, or have a negative pregnancy test. All participants who can have children must agree to use effective birth control during the study and for 30 days after.
Exclusion criteria: The study excludes patients with a different type of IBS, those outside the specified age range, people with other interfering medical conditions, those taking medications that could affect results, recent participants in other trials, pregnant or breastfeeding women, people with severe allergies to medications, those with a history of substance abuse, patients unable to comply with procedures, and those with conditions making participation unsafe.
Focus: The trial evaluates how effective and safe GSL-01-001 is in managing symptoms like abdominal pain, bloating, and diarrhea. Participants report symptoms regularly, and the study tracks changes in abdominal pain and stool consistency while monitoring safety throughout the 12-week treatment period.
Investigational drugs: GSL-01-001 is an experimental gastrointestinal medication containing cannabidiol, marketed as Arvisol 150mg. It is being tested to determine its effectiveness and safety in alleviating symptoms associated with diarrhea-predominant IBS.
Study of Fecal Microbiota Transplantation in Capsule Form Compared to Placebo for Patients with Severe Irritable Bowel Syndrome
This trial tests Fecal Microbiota Transplantation, which involves transferring beneficial gut bacteria from healthy donors to patients. The treatment is given as oral capsules containing frozen fecal microbiota.
Inclusion criteria: Participants must be between 18 and 75 years old with a diagnosis of IBS according to Rome IV criteria, including any type: constipation-predominant, diarrhea-predominant, or mixed. They must have severe symptoms with an IBS Severity Scoring System score greater than 300, have tried at least two previous treatments that did not work effectively, have valid health insurance, be able to provide written informed consent, and women who can become pregnant must use effective birth control throughout the study.
Exclusion criteria: The study excludes people under 18 or over 65 years old, pregnant or breastfeeding women, those with a history of inflammatory bowel disease, people who have had abdominal surgery in the last 3 months, those currently using or having used antibiotics in the past 3 months, patients with active infections or fever, those with severe allergic reactions, people in other clinical trials, those unable to swallow capsules, patients with severe mental health conditions, those with drug or alcohol abuse in the past 12 months, people with severe immune disorders, those with uncontrolled diabetes or thyroid disease, patients with severe liver or kidney disease, people taking interfering medications, and those with known allergies to study medication components.
Focus: The research aims to determine if oral capsules containing fecal microbiota are effective in reducing severity of symptoms compared to placebo. The study monitors patients for 24 weeks to assess changes in symptoms and overall quality of life, evaluating how the treatment affects the balance of bacteria in the digestive system.
Investigational drugs: Fecal Microbiota Transplantation capsules contain processed and frozen fecal microbiota from healthy donors. This therapy works by introducing beneficial gut bacteria to restore the patient’s intestinal microbiome balance, potentially improving digestive function and reducing symptoms. The treatment represents a new frontier in gastrointestinal medicine leveraging the understanding of gut microbiota’s role in digestive health.
Summary
The seven ongoing clinical trials for Irritable Bowel Syndrome demonstrate diverse therapeutic approaches across Europe. Germany leads with three trials, all focusing on diarrhea-predominant or mixed-type IBS and testing natural compound-based treatments. This concentration suggests strong research interest in plant-based and natural remedies in German research institutions.
A notable trend is the focus on diarrhea-predominant IBS, with five of the seven trials specifically targeting this subtype. This reflects the significant unmet medical need for effective treatments for this particularly challenging form of the condition.
The trials explore three main therapeutic strategies: probiotic therapies using beneficial bacteria or yeast, plant-based formulations combining natural ingredients like myrrh and chamomile, and innovative microbiota transplantation approaches. France is conducting the most novel trial involving fecal microbiota transplantation in capsule form, representing a cutting-edge approach to restoring gut bacterial balance.
Most studies require participants to be between 18 and 75 years old, with one Polish trial having a narrower age range of 18 to 50 years. Treatment durations vary considerably, from 8 weeks to 26 weeks, reflecting different approaches to evaluating treatment effectiveness. All trials emphasize safety monitoring alongside effectiveness evaluation, ensuring that new treatments are both beneficial and well-tolerated by patients.
