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First Palatable Elemental Diet Effective at Managing SIBO, Peer-Reviewed Clinical Study Confirms

via Business Wire

mBIOTA Elemental™ eradicated small intestinal bacterial overgrowth (SIBO) in 83% of clinical trial participants, a new record for elemental diets attributed to first solving for patient experience.

mBIOTA Labs, an emerging medical food company revolutionizing medical nutrition for the management of gastrointestinal (GI) conditions, highlights expanded data findings from its prospective clinical trial indicating that its flagship product, mBIOTA Elemental™ diet, is a highly effective solution for the management of gastrointestinal disorders, specifically Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogen Overgrowth (IMO). The clinical research findings are published in Clinical Gastroenterology and Hepatology, awarded by the 2024 American College of Gastroenterology Annual Meeting, and were presented at the 2024 Digestive Disease Week and internationally at the 2024 Federation of Neurogastroenterology and Motility Meeting.

mBIOTA Elemental™ was designed by a SIBO patient, her gastroenterologists, and food scientists to address the historic issues of taste and tolerance with elemental diets to ultimately improve patient protocol compliance and health outcomes. It was used in the first prospective clinical trial of an elemental diet for patients with SIBO and/or IMO, which resulted in a 100% patient compliance rate - never before achieved with an elemental diet - with 83% of SIBO patients eradicating their SIBO and 73% of all patients eradicating their SIBO and/or IMO overall. Trial participants on average reported up to an 82% improvement in symptom severity across 12 common GI symptoms, from pain and gut distension to flatulence and urgency. No serious or severe adverse events were reported.

“The clinical trial using mBIOTA Elemental™ focused on confirming the clinical effectiveness, tolerance and safety of our palatable elemental diet formula for managing small intestinal bacterial overgrowth (SIBO) and intestinal methanogen overgrowth (IMO),” says Nicola Wodlinger, CEO of mBIOTA Labs. “Not only were we thrilled to see exceptionally high efficacy and patient compliance rates, but we were pleasantly surprised to see that it unlocked additional benefits not yet documented through the use of prior existing elemental diets, including notable visceral fat loss with minimal muscle loss. This is a strong testament to the impact of solving for the patient experience, offering providers and patients a solution that is both clinically effective and relatively easy for individuals to stick to throughout their protocol.”

Further, their palatable elemental diet proves to be a promising dietary intervention to provide sustained whole-body benefits, including but not limited to visceral fat loss and reduced brain fog and fatigue. The investigators included body weight, total body fat, and visceral fat area as key study metrics alongside breath composition and symptom questionnaires with a brain fog score over the exclusive two-week course of mBIOTA Elemental™. Resulting data supports that overall weight loss was primarily visceral fat loss of up to 11%, whereas prior elemental diets have been associated with overall weight loss - rather than a healthful visceral fat loss outcome - due to poor patient compliance, despite being nutritionally complete. Trial participants also exhibited an average of 68% improvement in brain fog scores, reflecting improved short-term memory and concentration.

“Struggling with debilitating gastroenterology symptoms takes over your life,” says Krystyna Houser, former SIBO patient and founder of mBIOTA Labs, named among 2025 Inc.’s Female Founder 500 list. “At mBIOTA, we’re working to find better ways to get patients back to their normal lives through science-backed functional nutrition. Thanks to that guiding focus, we’ve had great success in improving patient experiences. We were really excited to uncover additional health benefits of the mBIOTA Elemental diet protocol and look forward to discovering more.”

For more information on mBIOTA Labs, mBIOTA Elemental™, and related clinical findings, visit www.mBIOTA.com.

About mBIOTA Labs

mBIOTA Labs harnesses proprietary Amino Taste Modification Technology (ATMT) to create clinically proven, science-backed medical foods, designed to optimize gut health and overall well-being. Trusted by the medical community, mBIOTA’s mission is to empower individuals with evidence-based nutrition solutions that enhance quality of life. mBIOTA's award-winning, clinically proven, palatable elemental diet, mBIOTA Elemental™, revolutionizes medical nutrition for the dietary management of GI dysfunction, including small intestinal bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), intestinal methanogen overgrowth (IMO), eosinophilic esophagitis (EoE) and other conditions. For more information on mBIOTA Labs and mBIOTA Elemental™, visit www.mBIOTA.com.

It’s estimated that up to 22% of the population is living with SIBO, but due to the commonalities of symptoms between SIBO and other disorders, it’s difficult to identify the true prevalence of the condition. Further, patients with SIBO account for about 78% of patients with IBS, indicating that millions of patients are suffering from SIBO.

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