Study that aims to investigate how effective and safe the use of a novel modified release tablet formulation of Colesevelam hydrochloride-MMX is for patients with bile acid diarrhoea (BAD), randomly allocated to 2 different dose regimens of the active product or to the inactive placebo formulation.

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• 01. Prior and concomitant gastrointestinal diseases: a) Current or recurrent disease that could affect the ileum and the enterohepatic circulation of bile acids, including ileal resection or bypass, short bowel syndrome, radiation enteritis, chronic pancreatitis, known small intestine bacterial overgrowth; b) Cholecystectomy within 6 months prior to the screening visit; c) Inflammatory bowel disease, including known microscopic colitis; d) Bowel obstruction; e) Biliary obstruction; f) Acute suspected or proven infectious (viral or bacterial) gastroenteritis within the 8 weeks prior to screening; g) Acute suspected or proven gastroenteritis within the 8 weeks prior to screening; h) Positive for Clostridium difficile toxins as detected by appropriate specific test; i) Coeliac disease, if any of the followings apply: Positive coeliac serology (e.g., anti-tissue transglutaminase [anti-TTG] IgA or equivalent) without a confirmed prior diagnosis of coeliac disease, unless false positive determined by the investigator; Diagnosis of coeliac disease within 6 months prior to the screening visit; Known or suspected non-adherence to a gluten-free diet, based on clinical assessment or patient history; Persistent gastrointestinal symptoms or abnormal laboratory findings (e.g., elevated anti-TTG, iron deficiency, or abnormal inflammatory markers) suggestive of ongoing disease activity. Participants with prior diagnosis (i.e. made > 6 months prior to screening), who are on a strict gluten-free diet for ≥ 6 months with no recent (within 6 months) dietary lapses or gluten reintroduction, have no on-going coeliac disease-related symptoms, and have no abnormal serologic or histologic laboratory findings suggestive of active disease, may be included. A positive serology can also be considered provided they are false positive confirmed by the investigator. j) Current or recurrent diseases that could affect the colon including diverticulitis, collagenous colitis, colonic resection, toxic megacolon, fistula, perforation or abscess;
• 10. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study.
• 02. Prior and concomitant diseases other than gastroenteric: a) Fasting triglycerides level above 3.4 mmol/L (300.9 mg/dL); b) Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness; c) Any medical disorder that may require treatment or make the patient unlikely to fully complete the study or any condition that presents undue risk from the study medication or procedures; d) History of malignancy within the last 5 years prior to screening, with the following exception: localized malignancies that were completely resected, do not require on-going treatment, and have been in complete remission for at least 3 years prior to screening. e) Hyperthyroidism;
• 03. Previous unsuccessful treatments: unsuccessfully treating BAD with bile acid sequestrants (cholestyramine, colestipol or colesevelam) unless the reason for treatment failure was due to non-compliance/lack of tolerability;
• 04. Prior and concomitant treatments (not to be discontinued solely due to participation in the trial): a) Treatment with other bile acid sequestrants must be stopped within 3 days before screening; b) Treatment with glucagon like peptide (GLP)-1 or GLP-2 receptor agonists (e.g., liraglutide) within 4 weeks before screening; c) Treatment with cyclosporine within 1 month before screening; d) Any concomitant medication, which colesevelam may have an interaction with, whose administration cannot be suspended for the duration of the study and which cannot be administered separated from the study drug (at least 4 h prior to or after the administration of colesevelam); e) Any concomitant medication for diarrhoea-predominant irritable bowel syndrome within 1 week prior to screening; f) Treatment with antidiarrheal drugs except loperamide (which is not permitted in the 48 hours prior to screening; g) Treatment with drugs with a known pharmacological activity on 5-hydroxytryptamine (5-HT)4, 5-HT2b or 5-HT3 receptors (e.g., tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine cilansetron, alosetron) within 2 weeks before screening; h) Treatment with drugs affecting the function of the gastrointestinal tract, including opioids (e.g. morphine, oxycodone, codeine, methadone, fentanyl, tramadol) unless taken at a stable dose for at least 4 weeks prior to screening and maintained unchanged throughout the study, anticholinergic drugs (e.g., dicyclomine, hyoscyamine, propantheline), anti-nausea drugs (e.g. trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine), laxative drugs (e.g. lactulose, sorbitol or polyethylene glycol preparations), prokinetic drugs (e.g. cisapride, metoclopramide, prucalopride, domperidone) within 4 weeks before screening; i) Rectal treatments (other than topical steroids for the treatment of haemorrhoids) within 2 weeks before screening; J) Treatment with immunosuppressant or immunomodulator agents including monoclonal antibodies (for instance, infliximab, adalimumab, azathioprine, 6-mercaptopurine, cyclosporine, vedolizumab, tofacitinib, filgotinib, ozanimod, etc.), within 4 weeks prior to screening; k) Treatment with ustekinumab within 16 weeks prior to screening (due to its longer half-life compared other Disease Modifying AntiRheumatic Drugs - DMARD); l) Treatment with antibiotics within 2 weeks before screening; m) Treatment with non-steroidal anti-inflammatory drugs (e.g. aspirin or ibuprofen) within 7 days prior to screening. Prophylactic use of a stable dose of aspirin up to 100 mg/day for cardiac disease is permitted;
• 05. Inflammatory markers: C-reactive protein >1.0 mg/dL, abnormal faecal calprotectin >100 µg/g; (if considered clinically significant by the Investigator as indicating an active inflammatory, infectious, or systemic condition that may interfere with patient safety or BAD assessment);