Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Recruiting
Study of the effectiveness and safety of colesevelam hydrochloride for patients with moderate-to-severe bile acid diarrhoea.
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study aims to evaluate the effectiveness and safety of a new version of colesevelam hydrochloride for the treatment of Bile Acid Diarrhoea, a condition where the body has too much bile acid, leading to frequent and urgent bowel movements. Participants may also be taking loperamide hydrochloride, a medication used to slow down the movement of the intestines. The study compares the new form of colesevelam hydrochloride, referred to by the code SUB01423MIG, against a placebo.
During the study, participants will be assigned to different groups to receive either the test medication or a placebo. The medication is provided in the form of a gastro-resistant tablet, which is a pill designed to pass through the stomach without dissolving immediately so that it can work later in the digestive system. The course of the study involves a period of monitoring followed by a 12-day treatment period with a stable dose of the medication.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- You must provide your signed written informed consent, which means you agree to participate in the study after being given all the necessary information.
- You must be a man or a woman who is at least 18 years old but younger than 80 years old.
- You must have moderate-to-severe bile acid diarrhoea, which is a condition where your body has too much bile acid in the gut, causing frequent bowel movements.
- Your condition must be confirmed by a 75SeHCAT scintigraphy, a special medical imaging test used to measure how much bile acid your body absorbs, showing a result of 10% or less.
- You must have active disease, meaning you are currently experiencing symptoms such as having an average of 3 or more bowel movements per day, or at least one watery stool (very loose bowel movement) every day.
- You must be willing and able to follow all the rules and tasks required by the study protocol, which is the official plan and set of instructions for the clinical trial.
- Women who are able to become pregnant must have a negative pregnancy test before starting the study medication.
- Women who can become pregnant must use a highly effective method of contraception, such as an IUD (a device placed in the uterus), hormonal methods like implants or pills, or have a partner who has had a vasectomy (a procedure for men to prevent pregnancy).
- Barrier methods, such as condoms or diaphragms, are not considered highly effective enough to be used alone during this study.
- If you use oral contraceptive pills, you must ensure they are taken at least four hours before or after the study medication to avoid interference.
- Women who are postmenopausal (not having periods for at least 12 months after stopping hormone therapy) or who have had permanent sterilization (such as hysterectomy or tubal ligation) are not considered to be at risk of pregnancy.
Who cannot join the trial?
34 criteria
- Having confirmed organic gastrointestinal diseases, which means physical problems or damage in the digestive system, such as celiac disease (an immune reaction to gluten), inflammatory bowel diseases like Crohn's Disease or ulcerative colitis (conditions that cause swelling in the digestive tract), diverticular disease, infectious colitis (inflammation caused by infection), ischemic colitis (inflammation caused by low blood flow), or microscopic colitis.
- A history of acute myocardial infarction (a heart attack), or stable or unstable angina (chest pain caused by reduced blood flow to the heart).
- A history of stroke or transient ischemic attack (a temporary period of symptoms similar to a stroke) within 6 months before the first study visit.
- Having any other serious or unstable disease that, according to the doctor, might make it unsafe to participate or could interfere with how the study is measured.
- Any major unstable psychiatric disorder, including eating disorders, or using antidepressant or anxiolytic (anti-anxiety) medicines, unless the dose has been the same for at least 6 weeks before the study starts.
- Having fasting triglycerides (a type of fat found in the blood) levels higher than 3.4 mmol/L at the first visit.
- A known allergy, hypersensitivity (an extreme immune response), or intolerance to colesevelam or any of the ingredients used to make the medicine.
- A known allergy to the 75SeHCAT test or its ingredients.
- Using bile acid sequestrants (medicines that bind to bile acids to remove them from the body), such as cholestyramine, colestipol, or colesevelam, within 1 week before the first visit.
- Having previously tried colesevelam for bile acid diarrhoea (BAD) without success.
- Currently taking oral anticoagulants (blood thinners), such as warfarin or newer types of blood thinners.
- Having severe gastrointestinal motility disorders (problems with how food moves through the digestive tract) or diseases affecting the ileum (the last part of the small intestine), the enterohepatic circulation (the process where the liver recycles bile), or the colon (the large intestine). This includes conditions like gastroparesis (slow stomach emptying), intestinal pseudo-obstruction (the gut acts like it is blocked but isn't), short bowel syndrome, chronic pancreatitis (long-term inflammation of the pancreas), or small intestine bacterial overgrowth.
- Having undergone surgery such as gastric or ileal resection (removal of part of the stomach or small intestine), colonic resection (removal of part of the colon), or having a fistula (an abnormal connection between organs), perforation (a hole in the digestive tract), or an abscess (a pocket of infection).
- Current treatment with drugs that change the intestinal pH (the acid levels in the gut), such as Proton Pump Inhibitors (acid reducers), H2-receptor antagonists, or antacids. For Proton Pump Inhibitors, you must have stopped taking them for at least 4 weeks before the first visit.
- Current treatment with drugs that change how fast food moves through the gut, such as prokinetics (drugs that speed up movement), GLP-1 receptor agonists, or drugs that cause constipation or diarrhea.
- Using laxatives (medicine to help with bowel movements) or anti-diarrheal drugs (medicine to stop diarrhea) at the start of the study, except for loperamide which can be used if needed. This includes opioids (strong pain medicines) and antispasmodics (medicines to stop muscle spasms).
- Using any rectal treatments (medicines applied to the rectum) in the 2 weeks before the first visit, except for topical steroids for haemorrhoids (swollen veins in the rectum).
- Using antibiotics in the 2 weeks before the first visit.
- Using immunosuppressant or immunomodulator medicines (drugs that change how the immune system works), including monoclonal antibodies, in the 6 weeks before the first visit.
- Using cyclosporine (an immune system medicine) in the 2 months before the first visit.
- Taking medications that might not work correctly if taken with colesevelam, such as certain blood pressure medicines, diabetes medicines, thyroid medicines, or oral contraceptives (birth control), unless they are taken at least 4 hours before or after the study medicine.
- Using statins or fenofibrate (medicines used to lower cholesterol).
- A history of drug abuse or use of illegal drugs.
- Alcohol abuse, defined as drinking more than 2 units per day or 10 units per week, or having a history of alcoholism.
- Having a known or suspected blockage in the bowel (intestines) or biliary duct (the tubes that carry bile).
- Participating in other clinical trials at the same time or within 90 days before the first visit.
- Being pregnant or breastfeeding during the entire study.
- Having dysphagia (difficulty swallowing).
- Having had major abdominal surgery, such as a bowel ostomy (creating an opening for waste), unless it was a simple surgery like an appendectomy (appendix removal) or caesarean section (C-section) that occurred more than 6 months ago.
- Having a suspected or proven viral gastroenteritis (stomach flu caused by a virus) within 4 weeks before the first visit.
- Having a suspected or proven non-viral gastroenteritis (stomach inflammation not caused by a virus) within 8 weeks before the first visit.
- Having an active malignancy (active cancer) of any type, except for certain common skin cancers.
- Having severe heart failure, severe renal impairment (severe kidney problems), or severe hepatic impairment (severe liver problems).
- Having abnormal liver enzymes, which are proteins in the blood that show if the liver is damaged, such as high levels of AST, ALT, or bilirubin.
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Azienda Ospedaliero Universitaria Pisana
VerifiedPisa, ItalyAzienda Unita Sanitaria Locale Di Bologna
VerifiedBologna, Italy
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Investigated drugs
Colesevelam
is a medication taken by mouth in tablet form. It is being studied to see how well it works to treat bile acid diarrhea by helping to manage the effects of bile acids in the digestive system.
Loperamide
is a medication taken by mouth in tablet form. It is used as a background treatment to help control or reduce the symptoms of diarrhea.
What is already known about the treatment
Colesevelam hydrochloride
This medication is taken by mouth in the form of a tablet designed to resist stomach acid. It is an established treatment used to help lower cholesterol and manage bile acid diarrhea. On a molecular level, it works by binding to bile acids in the digestive tract, which prevents them from being absorbed into the bloodstream and helps them leave the body through waste. This substance belongs to a class of drugs known as bile acid sequestrants.
Loperamide hydrochloride
This medicine is administered orally in tablet form. It is a widely used treatment for managing symptoms like diarrhea. It works by slowing down the movement of the muscles in the intestines, which allows the body to absorb more water and makes bowel movements firmer. This medication is classified as an antidiarrheal agent.
Investigated diseases
Bile acid diarrhoea - This condition occurs when there is an excess of bile acids in the large intestine. Bile acids are substances produced by the liver to help digest fats. When they are not properly reabsorbed in the small intestine, they pass into the colon. This presence of bile acids in the colon causes water and electrolytes to be drawn into the bowel. As a result, the condition typically progresses as frequent, watery stools and a sudden, urgent need to have a bowel movement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523868-20-00Protocol codeF106-CT01Estimated enrolment50 patientsSponsorMonteresearch S.r.l.
sourced from the EU Clinical Trials Register and site verification
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