Ongoing Clinical Trials for Diarrhoea
There are currently 3 clinical trials investigating treatments for diarrhoea, specifically focusing on bile acid diarrhea and antibiotic-related diarrhea in critically ill patients. These studies are testing medications and therapeutic approaches including bile acid sequestrants, statins, and faecal microbiota transplantation across Denmark, Belgium, and Czechia.
Clinical trial locations
- Belgium
- Czechia
- Denmark
Study on the Effectiveness and Safety of Colesevelam Hydrochloride for Patients with Idiopathic Bile Acid Diarrhea (BAD)
This trial is evaluating a modified-release tablet formulation of Colesevelam hydrochloride for patients experiencing idiopathic bile acid diarrhea. This condition occurs when the body has difficulty absorbing bile acids, substances the liver produces to help digest fats, leading to frequent watery bowel movements.
Who can participate: The study is open to men and women aged 18 years and older who have a diagnosis or symptoms of bile acid diarrhea, confirmed by specific blood test results and bowel movement patterns. Women of childbearing potential must use reliable birth control methods and have a negative pregnancy test. Participants need to understand the study requirements and complete a symptom diary for at least 3 consecutive days or 4 nonconsecutive days within a week before starting.
Who cannot participate: The trial excludes patients without a confirmed diagnosis of idiopathic bile acid diarrhea, those outside the specified age range, pregnant or breastfeeding women, and individuals currently participating in another clinical trial. Patients with other medical conditions that might interfere with the study, those with a history of substance or alcohol abuse, recent major surgery, or known allergies to the study medication are also excluded.
Study focus: The eight-week study aims to determine whether the new tablet formulation can reduce the number of days with loose stools and improve overall bowel movement patterns. Participants will be randomly assigned to receive either the active medication in two different dose regimens or a placebo. Throughout the trial, patients will keep a daily diary recording their bowel movements using the Bristol Stool Form Scale. Follow-up assessments will occur at weeks 2, 4, and 8 to evaluate treatment response and monitor for side effects.
Investigational treatment: Colesevelam hydrochloride is a bile acid sequestrant that works by binding to bile acids in the intestines, preventing their reabsorption and thereby reducing symptoms. This phase II trial is testing a modified-release tablet taken orally.
Study on the Effects of Atorvastatin in Patients with Moderate to Severe Bile Acid Diarrhea
This trial is investigating whether atorvastatin, a medication commonly used to lower cholesterol, can help reduce bile acid production in patients with moderate to severe bile acid diarrhea. When the body produces too much bile acid, it can irritate the colon and lead to frequent, watery bowel movements.
Who can participate: The study is open to both males and females within a specified age range who have a confirmed diagnosis of moderate to severe bile acid diarrhea, meaning their SeHCAT test result is 10% or less. Participants must be able to give informed consent and participate fully in the study.
Who cannot participate: Patients without a diagnosis of bile acid diarrhea, those outside the specified age range, pregnant or breastfeeding women, and individuals unwilling to follow study procedures cannot participate. The trial also excludes patients with other significant health issues that might interfere with the study and those currently participating in another clinical trial.
Study focus: The trial aims to determine if atorvastatin can effectively lower bile acid levels in the body, which may help improve symptoms. Participants will receive either atorvastatin (40 mg) or a placebo in the form of a film-coated tablet taken orally. Throughout the study, researchers will monitor changes in bile acid production by measuring a marker called C4. Participants will also keep a 7-day stool diary to record the frequency and consistency of stools, helping assess the treatment’s impact.
Investigational treatment: Atorvastatin works by inhibiting an enzyme involved in cholesterol production, which may in turn lower bile acid synthesis. This statin medication is being investigated for its potential to manage bile acid diarrhea through reducing bile acid production.
Study on Allogeneic Faecal Microbiota for Treating Antibiotic-Related Diarrhea in Critically Ill Patients
This clinical trial is studying the use of faecal microbiota transplantation to treat post-antibiotic diarrhea in critically ill patients. This condition occurs when antibiotics disrupt the normal balance of bacteria in the gut, leading to an overgrowth of harmful bacteria and frequent, watery bowel movements.
Who can participate: The study is open to patients over 18 years old who are currently in an Intensive Care Unit, High Dependency Unit, or burn unit with an expected stay of more than 7 days. Participants must have post-antibiotic diarrhea, defined as having 3 or more loose stools per day or very watery stool in a volume greater than 300 ml per day, persisting for 24 hours even after stopping tube feeding. Signed informed consent is required.
Who cannot participate: Patients who are unable to receive the assigned treatment for any reason or who still have diarrhea on day 7 after being assigned to a treatment group are excluded from the trial.
Study focus: The trial aims to evaluate how effective faecal microbiota transplantation is in reducing symptoms of post-antibiotic diarrhea in critically ill patients. The study will compare outcomes between patients receiving the treatment and those who do not, assessing treatment failure rates at day 7. Researchers will monitor for potential side effects such as new infections or other serious health issues. The ultimate goal is to determine the percentage of patients who recover from diarrhea and remain symptom-free by hospital discharge or by day 28, whichever comes first.
Investigational treatment: Faecal bacteriotherapy, also known as MaaT 033 in this study, involves transferring healthy bacteria from donor stool into the patient’s gut via a gastroenteral suspension. This microbiome-based therapy works by reintroducing beneficial bacteria to outcompete harmful bacteria and restore the natural balance in the gut, helping it recover from antibiotic-induced disruption.
Summary
These three clinical trials represent different approaches to managing diarrhea in specific patient populations. Two trials focus on bile acid diarrhea, testing different therapeutic strategies: one using a bile acid sequestrant to bind excess bile acids, and another using a statin to reduce bile acid production. The third trial addresses a different cause of diarrhea in critically ill patients who have received antibiotics, testing a microbiome-based approach to restore gut health.
Denmark is hosting two of the three trials, making it a notable center for this research, particularly for bile acid diarrhea studies. Belgium and Czechia each host one trial. The studies vary in their target populations, from adults with idiopathic bile acid diarrhea to critically ill patients in intensive care settings, reflecting the diverse nature of diarrheal conditions and the need for tailored treatment approaches.
