mBIOTA Elemental™ clinical trial achieves first perfect compliance rate for an orally-ingested elemental diet 

mBIOTA Labs, a medical food company revolutionizing oral nutrition through their proprietary palatable elemental diet, mBIOTA Elemental™, today announced the initial study results of their first prospective clinical trial assessing the efficacy of the mBIOTA Elemental™ diet in patients with small intestinal bacterial overgrowth (SIBO), intestinal methanogen overgrowth (IMO), or a combination of the two.

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mBIOTA prospective clinical trial: clinical eradication rates of SIBO and/or IMO by patient cohort, based on normalization of patient's lactulose breath test after day 14 of exclusive elemental diet (Graphic: Business Wire)

Presented in an abstract at Digestive Disease Week 2024, data from the trial revealed 100% of SIBO-only participating patients completely eradicated their SIBO after completing the two-week course of orally-ingested mBIOTA Elemental™ and 73% of patients eradicated their SIBO/IMO overall. Notably, participants achieved a groundbreaking 100% compliance rate, with all patients successfully completing the two-week course of the mBIOTA Elemental™ diet. The trial was conducted in November 2023 at Cedars-Sinai Medical Center in Los Angeles, California.

“These exciting results exceeded our expectations and offer hope to the millions of SIBO and IMO patients who have previously struggled to complete an elemental diet or discounted this highly effective treatment entirely due to lack of awareness or hesitation regarding its palatability,” says Nicola Wodlinger, CEO of mBIOTA Labs. “With mBIOTA Elemental™, we are prioritizing the patient experience without sacrificing efficacy and, as indicated in the results of our first clinical trial, creating an incredible opportunity for gastroenterologists to help patients manage GI dysfunction. We hope to help more and more patients and providers experience the benefits of the mBIOTA Elemental™ diet and expand its clinical applications in the coming years.”

For more than 50 years and across hundreds of clinical studies, doctors and scientists have demonstrated the clinical effectiveness of elemental diets for the management of a wide range of gastrointestinal diseases. However, due to the traditionally unpalatable taste of elemental diets, they are infrequently used as patient compliance is challenging. The introduction of mBIOTA’s truly palatable elemental diet this year now offers patients an approachable and clinically reliable option to manage GI disorders like SIBO and IMO.

To learn more about mBIOTA Labs and mBIOTA Elemental™, visit www.mbiotaelemental.com.

About mBIOTA Labs mBIOTA Labs specializes in the development of medical foods for gastrointestinal (GI) dysfunction. mBIOTA Labs is revolutionizing oral nutrition with their proprietary product, mBIOTA Elemental™ diet, a medical food designed to address the historic issues with elemental diets: poor taste and patient compliance. Developed in partnership with leading gastroenterologists and food scientists for the dietary management of GI dysfunction, including small intestinal bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), and other conditions, the highly palatable mBIOTA Elemental™ diet delivers essential nutrients, vitamins and minerals in a readily absorbable formula. For more information on mBIOTA Labs and mBIOTA Elemental™, visit www.mbiotaelemental.com.

About DDW Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 18-21, 2024. The meeting showcases more than 4,400 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

Media Contact for mBIOTA Labs: Matter Communications mbiota@matternow.com