![]() ![]() Traverso envisions applications for this therapeutic far beyond IBS-C. Within the next 18 months, clinical trials will begin for the bilayered delivery of CDC to IBS-C patients, with pill production regulated by the team's newly founded Bilayer Therapeutics. Several important limitations exist for this study, including lack of similar studies for comparison and shortcomings of the swine model the team was not able to measure levels of abdominal pain in the swine model, and only rectal contractions were measured, as opposed to a full colonic evaluation. This biphasic release of CDC established a low-dose, long-lasting presence of bile acid over time, avoiding the dosage spike and decreasing cramping. ![]() ![]() Immediate release of the pill's surface layer established a healthy local concentration of CDC, which in turn offered enough colonic fluid to initiate the pill's second, slower-release layer of CDC. The bilayered delivery mechanism was tested in swine models for half-life, colon cramping and whether it caused a similar dosage spike to single-layered delivery. The challenge has been how to administer these in ways that minimize potential side effects to accomplish this, researchers developed a bilayered delivery system. Bile acids, such as pro-motility CDC, have been previously studied in patients for their pro-motility effects and recognized to enhance water ingression and bowel motility. The liver produces bile acids to aid in the digestive process, regulating intestinal motility, fluid homeostasis, and humoral activity. "Could we take this endogenous, natural product and deliver it in a way that overcomes this risk of contractions?" This manifests in increased bowel movements, but also pain," said Giovanni Traverso, MD, PhD, of the Brigham's Division of Gastroenterology, Hepatology and Endoscopy and the Department of Mechanical Engineering at MIT. "We know bile acids are capable of helping with motility, but what has been attempted in the past is giving a bolus - a boatload of bile acid all at once. Findings are published in Clinical and Translational Gastroenterology. ![]()
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