{"product_id":"colesevelam-for-bile-acid-diarrhoea-what-the-new-sinbad-trial-means-for-patients","title":"Colesevelam for Bile Acid Diarrhoea: What the New SINBAD Trial Means for Patients","description":"\u003cp\u003eBile acid diarrhoea is a common yet frequently overlooked cause of chronic watery diarrhoea, affecting an estimated 1% of the general population. A new phase 4 clinical trial, the SINBAD study, tested the medication colesevelam against placebo in 168 patients with confirmed diarrhoea and found that 64% of patients with C4-diagnosed bile acid diarrhoea achieved remission on colesevelam compared with only 16% on placebo—a statistically powerful result. The treatment was safe, with no serious adverse events and no patients withdrawing due to side effects. This study provides the strongest evidence yet that colesevelam is an effective and well-tolerated treatment for bile acid diarrhoea, validating the use of the widely accessible C4 blood test for diagnosis.\u003c\/p\u003e\n\n\u003ch1\u003eColesevelam for Bile Acid Diarrhoea: What the New SINBAD Trial Means for Patients\u003c\/h1\u003e\n\n\u003ch2\u003eTable of Contents\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#ddn-key-points\"\u003eKey Points\u003c\/a\u003e\u003c\/li\u003e\n\n  \u003cli\u003e\u003ca href=\"#background\"\u003eUnderstanding Bile Acid Diarrhoea\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#why-needed\"\u003eWhy This Study Was Needed\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#study-design\"\u003eHow the Study Was Conducted\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#participants\"\u003eWho Took Part in the Study\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#treatment\"\u003eThe Treatment Plan\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#key-findings\"\u003eKey Findings: Does Colesevelam Work?\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#safety\"\u003eSafety and Side Effects\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#implications\"\u003eWhat This Means for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#limitations\"\u003eStudy Limitations\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#recommendations\"\u003eRecommendations for Patients\u003c\/a\u003e\u003c\/li\u003e\n  \u003cli\u003e\u003ca href=\"#ddn-faq\"\u003eFrequently Asked Questions\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#source\"\u003eSource Information\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003c!-- ddn:keypoints:start --\u003e\n\u003ch2 id=\"ddn-key-points\"\u003eKey Points\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eIn the SINBAD trial, 64% of C4-confirmed bile acid diarrhoea patients achieved remission on colesevelam versus 16% on placebo.\u003c\/li\u003e\n\u003cli\u003eColesevelam raised remission odds about ninefold in C4-diagnosed patients and about elevenfold in SeHCAT-diagnosed patients.\u003c\/li\u003e\n\u003cli\u003eThe SINBAD trial reported no serious adverse events; bloating and abdominal pain were the most common side effects.\u003c\/li\u003e\n\u003cli\u003eThe C4 blood test identified patients who responded as well to colesevelam as the SeHCAT scan, supporting wider use.\u003c\/li\u003e\n\u003cli\u003eTreatment in the trial lasted 12 days, with remission defined as fewer than 3 total and fewer than 1 watery stool daily.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003c!-- ddn:keypoints:end --\u003e\n\n\n\u003ch2 id=\"background\"\u003eUnderstanding Bile Acid Diarrhoea\u003c\/h2\u003e\n\n\u003cp\u003eBile acid diarrhoea (BAD) is a chronic condition caused by an excess of bile acids reaching the colon (large intestine). Normally, bile acids—produced by the liver to help digest fats—are reabsorbed in the final part of the small intestine. When this process fails or bile acid production exceeds absorption, the excess acids spill into the colon, where they trigger increased fluid secretion and faster bowel transit. The result is chronic, watery diarrhoea that can significantly impair quality of life.\u003c\/p\u003e\n\n\u003cp\u003eThe condition is far from rare. The estimated population prevalence is approximately \u003cstrong\u003e1%\u003c\/strong\u003e, meaning roughly one in every hundred people may be affected. Yet it is frequently overlooked or misdiagnosed.\u003c\/p\u003e\n\n\u003cp\u003eOne striking statistic from the study highlights this diagnostic gap: when patients with irritable bowel syndrome (IBS) are formally tested for bile acid diarrhoea, \u003cstrong\u003e29–35% \u003c\/strong\u003eturn out to have BAD instead. This means that a substantial proportion of people diagnosed with IBS may actually have a treatable bile acid problem.\u003c\/p\u003e\n\n\u003ch2 id=\"why-needed\"\u003eWhy This Study Was Needed\u003c\/h2\u003e\n\n\u003cp\u003eDiagnosing bile acid diarrhoea is not straightforward. The gold standard test is the SeHCAT test (tauroselcholic [⁷⁵Se] acid), a nuclear medicine scan that measures how much of a radiolabelled bile acid is retained in the body over one week. However, this test is available only in specialised centres in a limited number of countries. An alternative is a blood test measuring \u003cstrong\u003eplasma 7α-hydroxy-4-cholesten-3-one (C4)\u003c\/strong\u003e, a by-product of bile acid production. The C4 test is potentially more widely available, but it has roughly 50% sensitivity compared with the SeHCAT test—meaning it can miss about half of cases.\u003c\/p\u003e\n\n\u003cp\u003eEven with an accurate diagnosis, there has been a significant evidence gap. The mainstay of treatment has been bile acid sequestrants—medications that bind bile acids in the colon and neutralise their diarrhoea-inducing effects. The oldest of these, colestyramine, has been used for over 50 years. A newer option, \u003cstrong\u003ecolesevelam\u003c\/strong\u003e, binds bile acids more strongly and across a broader spectrum of bile acid types. Clinical data from cholesterol treatment suggest colesevelam also has fewer side effects and better tolerability than the older sequestrants.\u003c\/p\u003e\n\n\u003cp\u003eHowever, the evidence supporting these drugs for BAD has been weak. Observational (non-randomised) studies have reported remission rates of \u003cstrong\u003e70–90%\u003c\/strong\u003e with sequestrants, but placebo-controlled trials have been scarce and inconclusive. One small trial using enterocoated colestyramine in 14 selected patients with Crohn's disease and small bowel resection showed some benefit. But the few controlled trials in broader populations did not show colestyramine or colesevelam to be superior to placebo regarding bowel habits, although some secondary non-clinical measurements did improve.\u003c\/p\u003e\n\n\u003cp\u003eThis left a critical question unanswered: do these medications genuinely work for bile acid diarrhoea when tested in a rigorous, blinded, placebo-controlled design? The SINBAD trial (Sequestrant colesevelam in bile acid diarrhoea) was designed to answer this.\u003c\/p\u003e\n\n\u003ch2 id=\"study-design\"\u003eHow the Study Was Conducted\u003c\/h2\u003e\n\n\u003cp\u003eThe SINBAD trial was an investigator-initiated, multicentre, double-blind, randomised, placebo-controlled, phase 4 clinical trial. It was conducted at four Danish secondary care centres. The researchers enrolled consecutive patients who were already being referred for routine SeHCAT testing because a doctor suspected bile acid diarrhoea. The study ran between \u003cstrong\u003eOctober 25, 2018, and July 1, 2021\u003c\/strong\u003e, with the final patient chart review completed on February 13, 2022.\u003c\/p\u003e\n\n\u003cp\u003eThe trial used a rigorous design to ensure unbiased results. Both patients and study personnel were blinded—meaning neither knew whether the patient was receiving the active drug or a placebo. A pharmacist with no involvement in patient care generated the randomisation list using a web-based tool, with block randomisation (using blocks of 2, 4, or 6 patients) to keep the group sizes balanced across the study sites.\u003c\/p\u003e\n\n\u003cp\u003eSealed emergency envelopes were created in case a treatment allocation ever needed to be revealed urgently. Reassuringly, \u003cstrong\u003eno envelope was ever opened\u003c\/strong\u003e during the study. The randomisation code remained fully masked until after the final 6-month follow-up, and the envelopes were only opened on February 14, 2022—after all data had been collected and locked.\u003c\/p\u003e\n\n\u003cp\u003eSome additional design details are worth noting for completeness:\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003ePlacebo capsules contained 330 mg lactose monohydrate, 335 mg potato starch, 12 mg gelatin, 3.5 mg magnesium stearate, and 31.5 mg talcum.\u003c\/li\u003e\n  \u003cli\u003eActive capsules contained 625 mg colesevelam hydrochloride.\u003c\/li\u003e\n  \u003cli\u003eBoth were over-encapsulated in identical Capsugel DBcaps size AAA shells, with 360 mg microcrystalline cellulose filling surplus space.\u003c\/li\u003e\n  \u003cli\u003eDuring the study, the C4 reference laboratory was changed from Hôpital Saint-Antoine in Paris to Rigshospitalet in Copenhagen due to a calibrator error in the Paris lab. This change happened before treatment allocation was unmasked, and Copenhagen results were confirmed by a second independent laboratory.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"participants\"\u003eWho Took Part in the Study\u003c\/h2\u003e\n\n\u003cp\u003eThe researchers screened a large pool of potential participants. In total, \u003cstrong\u003e1,124 patients were prescreened\u003c\/strong\u003e, and 168 patients were ultimately randomly assigned to receive either colesevelam (n=84) or placebo (n=84).\u003c\/p\u003e\n\n\u003cp\u003ePatients were eligible if they were aged 18 to 79 years, did not have inflammatory bowel disease (IBD), and were attending SeHCAT testing for suspected bile acid diarrhoea. Key exclusions included patients with inflammatory bowel disease, microscopic colitis, suspected or confirmed viral gastroenteritis within the previous 4 weeks, acute non-viral gastroenteritis within the previous 8 weeks, or any debilitating chronic disease as judged by the study investigator.\u003c\/p\u003e\n\n\u003cp\u003eA crucial practical element of the design was the baseline diarrhoea confirmation. Before randomisation, all patients kept a structured diary for 6 complete days (the week required for SeHCAT testing). Diarrhoea was defined as a daily average of \u003cstrong\u003e3.0 or more total bowel movements\u003c\/strong\u003e or \u003cstrong\u003e1.0 or more watery bowel movements\u003c\/strong\u003e (Bristol stool scale types 6 and 7—the \"fluffy\" or entirely liquid forms). Only patients who met this diary-confirmed definition were randomised.\u003c\/p\u003e\n\n\u003cp\u003eAmong the 168 randomised patients, 41 had a C4 concentration greater than 46 ng\/mL (22 assigned to colesevelam and 19 assigned to placebo)—this was the primary analysis population. An additional 75 patients had SeHCAT retention of 10% or less (37 in the colesevelam group and 38 in the placebo group), which defined the secondary analysis population. Patients with a normal C4 or SeHCAT result were classified as having \"miscellaneous diarrhoea\" and were analysed in exploratory analyses.\u003c\/p\u003e\n\n\u003ch2 id=\"treatment\"\u003eThe Treatment Plan\u003c\/h2\u003e\n\n\u003cp\u003eTreatment lasted 12 days. The starting dose was \u003cstrong\u003etwo capsules of 625 mg twice daily\u003c\/strong\u003e (a total daily dose of 2,500 mg). During the first 5 days—a designated run-in period—blinded study personnel telephoned patients to adjust the dose based on their response. Unless the patient reported constipation, the dose was increased stepwise.\u003c\/p\u003e\n\n\u003cp\u003eThe allowed doses were:\u003c\/p\u003e\n\u003col\u003e\n  \u003cli\u003eOne capsule twice daily (1,250 mg\/day)\u003c\/li\u003e\n  \u003cli\u003eTwo capsules twice daily (2,500 mg\/day)\u003c\/li\u003e\n  \u003cli\u003eThree capsules twice daily (3,750 mg\/day) — \u003cstrong\u003ethe target dose\u003c\/strong\u003e\n\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003eDose changes were made in steps of one capsule per dose. Once the final dose was set during the 5-day titration period, it was kept unchanged for the remaining 7 treatment days. No dietary advice was given during the study.\u003c\/p\u003e\n\n\u003cp\u003ePatients continued their diary recordings throughout treatment. Remission was defined as the \u003cstrong\u003eabsence of both diarrhoea criteria\u003c\/strong\u003e (fewer than 3.0 total bowel movements per day AND fewer than 1.0 watery bowel movement per day) during treatment days 6 through 12. Additional questionnaires measured quality of life and gastrointestinal symptoms, and voluntary stool samples were collected for bile acid analysis.\u003c\/p\u003e\n\n\u003cp\u003eThe primary outcome was the intention-to-treat remission rate in patients whose bile acid diarrhoea was diagnosed by a \u003cstrong\u003eC4 concentration greater than 46 ng\/mL\u003c\/strong\u003e. The key secondary outcome was the remission rate in patients diagnosed by \u003cstrong\u003eSeHCAT retention of 10% or less\u003c\/strong\u003e. In the intention-to-treat analysis, patients with missing outcome data were counted as treatment failures—a conservative approach. Once the trial ended, patients were followed up for 6 months, with symptom questionnaires repeated and patient charts reviewed for current treatment and its subjective effect.\u003c\/p\u003e\n\n\u003ch2 id=\"key-findings\"\u003eKey Findings: Does Colesevelam Work?\u003c\/h2\u003e\n\n\u003cp\u003eThe results were striking and strongly favour colesevelam.\u003c\/p\u003e\n\n\u003ch3\u003ePrimary Outcome: C4-Defined Bile Acid Diarrhoea\u003c\/h3\u003e\n\n\u003cp\u003eOf the 41 patients with C4-confirmed bile acid diarrhoea, \u003cstrong\u003e14 of 22 (64%)\u003c\/strong\u003e receiving colesevelam achieved remission, compared with \u003cstrong\u003e3 of 19 (16%)\u003c\/strong\u003e receiving placebo. The adjusted odds ratio was 9.1 (95% CI 1.9–62.8; p=0.011). In plain language, this means patients on colesevelam were about \u003cstrong\u003e9 times more likely\u003c\/strong\u003e to achieve remission than those on placebo, and the result was statistically significant—meaning there is a less than 1.1% probability this difference occurred by chance. This was the study's primary, pre-specified endpoint, making it a particularly robust finding.\u003c\/p\u003e\n\n\u003ch3\u003eSecondary Outcome: SeHCAT-Defined Bile Acid Diarrhoea\u003c\/h3\u003e\n\n\u003cp\u003eThe secondary outcome mirrored the primary result. Among the 75 patients with SeHCAT-defined bile acid diarrhoea, \u003cstrong\u003e22 of 37 (59%)\u003c\/strong\u003e in the colesevelam group achieved remission versus \u003cstrong\u003e5 of 38 (13%)\u003c\/strong\u003e in the placebo group. The adjusted odds ratio was an even more impressive 11.1 (95% CI 3.4–45.6; p=0.00020). This means patients were about \u003cstrong\u003e11 times more likely\u003c\/strong\u003e to achieve remission on colesevelam, and the probability of this being due to chance is less than 0.02%—an exceptionally strong statistical signal.\u003c\/p\u003e\n\n\u003ch3\u003eComparing the Two Diagnostic Approaches\u003c\/h3\u003e\n\n\u003cp\u003eThe consistency between the two diagnostic methods is an important finding. The C4 blood test—which is potentially more widely available than the specialised SeHCAT scan—identified a patient group that responded equally well to treatment. The remission rates were 64% for C4-diagnosed patients and 59% for SeHCAT-diagnosed patients, a very similar magnitude of benefit. This validates the C4 threshold of 46 ng\/mL as a clinically meaningful diagnostic cut-off.\u003c\/p\u003e\n\n\u003ch2 id=\"safety\"\u003eSafety and Side Effects\u003c\/h2\u003e\n\n\u003cp\u003eOne of the most reassuring aspects of this trial is the safety profile. There were \u003cstrong\u003eno serious adverse events\u003c\/strong\u003e in either group, and common adverse events were described as transient.\u003c\/p\u003e\n\n\u003cp\u003eIn the primary outcome population (patients with C4-defined bile acid diarrhoea), the side effects reported were:\u003c\/p\u003e\n\n\u003cp\u003eColesevelam group (22 patients):\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eAbdominal pain: 5 patients\u003c\/li\u003e\n  \u003cli\u003eBloating: 9 patients\u003c\/li\u003e\n  \u003cli\u003eNausea: 4 patients\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003ePlacebo group (19 patients):\u003c\/p\u003e\n\u003cul\u003e\n  \u003cli\u003eAbdominal pain: 4 patients\u003c\/li\u003e\n  \u003cli\u003eBloating: 4 patients\u003c\/li\u003e\n  \u003cli\u003eNausea: 1 patient\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003cp\u003eNotably, \u003cstrong\u003eno participants with bile acid diarrhoea withdrew from the study due to adverse events\u003c\/strong\u003e. Adverse events were recorded from the start of treatment until 72 hours after treatment ended, and patients documented any unusual symptoms and their duration in the study diary.\u003c\/p\u003e\n\n\u003ch2 id=\"implications\"\u003eWhat This Means for Patients\u003c\/h2\u003e\n\n\u003cp\u003eThe clinical significance of this trial is substantial. Before this study, evidence for bile acid sequestrants relied on observational data and a handful of small, inconclusive placebo-controlled trials. The SINBAD trial provides high-quality, phase 4 evidence that colesevelam is genuinely effective at treating bile acid diarrhoea when the diagnosis is confirmed by either C4 or SeHCAT testing.\u003c\/p\u003e\n\n\u003cp\u003eThe fact that \u003cstrong\u003etwo-thirds of patients achieved remission\u003c\/strong\u003e is a significant clinical benefit. Observational data further suggest that once remission is achieved, it is usually sustained over the longer term. This matters enormously for patients with chronic diarrhoea, who often suffer for years with misdiagnoses such as IBS before receiving appropriate treatment.\u003c\/p\u003e\n\n\u003cp\u003eThe trial also has an important diagnostic message. The C4 blood test is simpler and more accessible than the SeHCAT nuclear medicine scan, which is only available in specialised centres in a few countries. The finding that C4-diagnosed patients responded just as well to colesevelam lends strong support to using C4 as a practical diagnostic tool in wider clinical settings. For patients, this could mean faster diagnosis and treatment, without the practical barriers of travelling to specialist nuclear medicine departments.\u003c\/p\u003e\n\n\u003cp\u003eBased on the 29–35% detection rate of BAD in patients labelled with IBS, diagnosing and treating bile acid diarrhoea properly could have a meaningful impact on a very large group of patients experiencing chronic diarrhoea.\u003c\/p\u003e\n\n\u003ch2 id=\"limitations\"\u003eStudy Limitations\u003c\/h2\u003e\n\n\u003cp\u003eLike every clinical trial, this study has limitations that should be acknowledged. Understanding these helps patients judge the strength of the evidence.\u003c\/p\u003e\n\n\u003cul\u003e\n  \u003cli\u003e\n\u003cstrong\u003eShort treatment duration.\u003c\/strong\u003e The treatment and assessment period was only 12 days, with remission assessed during days 6–12. While this is sufficient to establish short-term efficacy, the study cannot directly prove that remission is maintained over months or years. The longer-term benefits are supported by observational data, not this trial.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eModest primary outcome population.\u003c\/strong\u003e Only 41 patients had C4-defined bile acid diarrhoea (the primary analysis group). Although the results were statistically significant, the confidence intervals were wide—the odds ratio for the primary outcome ranged from 1.9 to 62.8. This reflects the relatively small number of patients and means the precise magnitude of benefit is uncertain.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNo loperamide or other rescue medication.\u003c\/strong\u003e The study did not allow escape or rescue medication, which could have led to withdrawals or the classification of some patients as treatment failures.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eSpecific diagnostic thresholds.\u003c\/strong\u003e The study used C4 greater than 46 ng\/mL and SeHCAT retention of 10% or less. Different thresholds are used in some centres, and the results may not generalise to all diagnostic criteria.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAll patients had diarrhoea at baseline.\u003c\/strong\u003e The planned mixed-model analysis could not be used because all patients had diarrhoea at baseline, producing a singular fit correlation matrix. The researchers instead used logistic regression with site as a conditional effect.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eNo adjustment for multiple testing.\u003c\/strong\u003e Because multiple secondary outcomes were analysed without statistical adjustment, the secondary results should be interpreted as supportive rather than definitive.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eDrug interaction precautions.\u003c\/strong\u003e The study protocol paused other medications known to interact with sequestrants (statins and fibrates) during the treatment window, and patients with significant comorbid disease were excluded. Real-world patients taking multiple medications may need additional considerations.\u003c\/li\u003e\n\u003c\/ul\u003e\n\n\u003ch2 id=\"recommendations\"\u003eRecommendations for Patients\u003c\/h2\u003e\n\n\u003cp\u003eBased on this trial and the existing body of evidence, here is practical guidance for patients and clinicians navigating bile acid diarrhoea:\u003c\/p\u003e\n\n\u003col\u003e\n  \u003cli\u003e\n\u003cstrong\u003eIf you have chronic diarrhoea and have been told it is IBS, consider asking about bile acid diarrhoea.\u003c\/strong\u003e With a 29–35% prevalence of BAD in the IBS population, testing is strongly recommended in guidelines and could uncover a treatable cause.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eAsk about the C4 blood test.\u003c\/strong\u003e If SeHCAT scanning is not available in your area, the C4 blood test is a reasonable and potentially widely accessible diagnostic alternative. This trial confirms that a C4 concentration above 46 ng\/mL identifies patients who respond well to colesevelam.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eUnderstand that bile acid sequestrants are the standard treatment.\u003c\/strong\u003e Colesevelam is not a new or experimental drug—it has been used for hypercholesterolaemia (high cholesterol) for years, with a known and reassuring safety profile. This trial now confirms its effectiveness for bile acid diarrhoea.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eBe patient with dose adjustment.\u003c\/strong\u003e In this study, the dose was started at two capsules twice daily and titrated over the first 5 days toward a target of three capsules twice daily, based on response and tolerance. If your doctor prescribes colesevelam, some adjustment may be needed to find the dose that works for you.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eExpect possible mild side effects early in treatment.\u003c\/strong\u003e The most common side effects in this trial were bloating (9 of 22 patients on colesevelam in the primary group), abdominal pain (5 of 22), and nausea (4 of 22). These were transient and no patient with bile acid diarrhoea withdrew due to side effects.\u003c\/li\u003e\n  \u003cli\u003e\n\u003cstrong\u003eRemember that remission is achievable.\u003c\/strong\u003e In this trial, two-thirds of patients (64%) achieved full remission of their diarrhoea symptoms. If you have been living with chronic diarrhoea, effective treatment exists and is worth pursuing.\u003c\/li\u003e\n\u003c\/ol\u003e\n\n\u003cp\u003eThe researchers also called for future studies to improve biochemical diagnostic options, determine the role of newer treatments such as liraglutide in the treatment algorithm, and assess long-term outcomes including sustained remission, safety, and quality of life. But for now, the SINBAD trial provides solid, practice-changing evidence that colesevelam is an effective and safe option for patients with bile acid diarrhoea.\u003c\/p\u003e\n\n\u003c!-- ddn:faq:start --\u003e\n\u003ch2 id=\"ddn-faq\"\u003eFrequently Asked Questions\u003c\/h2\u003e\n\u003ch3\u003eWhat causes bile acid diarrhoea?\u003c\/h3\u003e\n\u003cp\u003eBile acid diarrhoea happens when excess bile acids reach the colon. Bile acids normally help digest fats and are reabsorbed in the small intestine, but when this fails, they spill into the colon, increasing fluid secretion and speeding bowel transit. This causes chronic watery diarrhoea. It affects about 1% of people and is often misdiagnosed as irritable bowel syndrome.\u003c\/p\u003e\n\u003ch3\u003eHow is bile acid diarrhoea diagnosed?\u003c\/h3\u003e\n\u003cp\u003eThe gold-standard test is the SeHCAT nuclear medicine scan, but it is only available in specialised centres. A simpler blood test measures C4, a by-product of bile acid production. In the SINBAD trial, a C4 level above 46 ng\/mL identified patients who responded well to treatment, although C4 testing can miss about half of cases.\u003c\/p\u003e\n\u003ch3\u003eWhat was the SINBAD trial?\u003c\/h3\u003e\n\u003cp\u003eSINBAD was a double-blind, randomised, placebo-controlled phase 4 trial conducted at four Danish centres. It enrolled 168 patients suspected of having bile acid diarrhoea. Participants received either colesevelam or placebo for 12 days, with dose adjustment in the first 5 days. Researchers measured remission using stool diaries and compared results between the two groups.\u003c\/p\u003e\n\u003ch3\u003eHow effective was colesevelam in the trial?\u003c\/h3\u003e\n\u003cp\u003eAmong patients with C4-confirmed bile acid diarrhoea, 64% on colesevelam achieved remission compared with 16% on placebo. In patients diagnosed by SeHCAT, 59% on colesevelam achieved remission versus 13% on placebo. This means colesevelam was about 9 to 11 times more likely to produce remission than placebo.\u003c\/p\u003e\n\u003ch3\u003eWho was eligible for the SINBAD trial?\u003c\/h3\u003e\n\u003cp\u003ePatients were aged 18 to 79, did not have inflammatory bowel disease, and were already being referred for SeHCAT testing because a doctor suspected bile acid diarrhoea. Before randomisation, everyone kept a 6-day stool diary confirming diarrhoea, defined as an average of 3 or more total bowel movements or at least 1 watery stool per day.\u003c\/p\u003e\n\u003ch3\u003eHow quickly can colesevelam relieve symptoms?\u003c\/h3\u003e\n\u003cp\u003eIn the SINBAD trial, treatment lasted 12 days. The dose was adjusted during the first 5 days, and remission was assessed during days 6 through 12. Remission meant having fewer than 3 total bowel movements and fewer than 1 watery bowel movement per day. Two-thirds of C4-confirmed patients achieved remission during this short period.\u003c\/p\u003e\n\u003c!-- ddn:faq:end --\u003e\n\n\u003ch2 id=\"source\"\u003eSource Information\u003c\/h2\u003e\n\n\u003cp\u003e\u003cstrong\u003eOriginal Article:\u003c\/strong\u003e \"Efficacy and safety of colesevelam for the treatment of bile acid diarrhoea: a double-blind, randomised, placebo-controlled, phase 4 clinical trial\"\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors:\u003c\/strong\u003e Christian Borup, Lars Vinter-Jensen, Søren Peter German Jørgensen, Signe Wildt, Jesper Graff, Tine Gregersen, Anna Zaremba, Trine Borup Andersen, Camilla Nøjgaard, Hans Bording Timm, Dominique Rainteau, Svend Høime Hansen, Jüri Johannes Rumessen, Lars Kristian Munck\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eJournal:\u003c\/strong\u003e The Lancet Gastroenterology \u0026amp; Hepatology, published online February 6, 2023\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOI:\u003c\/strong\u003e https:\/\/doi.org\/10.1016\/S2468-1253(22)00401-0\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c\/strong\u003e Fabrikant Vilhelm Pedersen og hustrus mindelegat; recommended by the Novo Nordisk Foundation. The funders had no role in study design, data collection, analysis, interpretation, or writing of the report.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration:\u003c\/strong\u003e ClinicalTrials.gov, NCT03876717; EudraCT, 2016–001452–22\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCopyright:\u003c\/strong\u003e © 2023 Published by Elsevier Ltd. All rights reserved.\u003c\/p\u003e\n\n\u003cp\u003e\u003cem\u003eThis patient-friendly article is based on peer-reviewed research. It is intended for educational purposes and does not constitute medical advice. Always consult your healthcare provider about diagnosis and treatment options.\u003c\/em\u003e\u003c\/p\u003e","brand":"DiagnosticDetectives.Com","offers":[{"title":"Default Title","offer_id":47457935589532,"sku":null,"price":0.0,"currency_code":"EUR","in_stock":true}],"url":"https:\/\/diagnosticdetectives.com.br\/products\/colesevelam-for-bile-acid-diarrhoea-what-the-new-sinbad-trial-means-for-patients","provider":"DiagnosticDetectives.Com","version":"1.0","type":"link"}