Company: mBIOTA Labs, Santa Monica, CA
Nominations Submitted by: Matter Now
Company Description: mBIOTA Labs specializes in the development of medical foods for gastrointestinal (GI) dysfunction, including small intestinal bacterial overgrowth (SIBO) and other conditions. 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.
Nomination Category: Company/Organization Awards Categories
Nomination Sub Category: Startup of the Year - Consumer Products Industries
 Nomination Title: mBIOTA Elemental – a Revolutionary Elemental Diet
- Which will you submit for your nomination in this category, a video of up to five (5) minutes, explaining the achievements since July 1, 2022 of the nominated organization, OR written answers to the questions? (Choose one):
Written answers to the questions
- If you are submitting a video of up to five (5) minutes in length, provide the URL of the video here, OR attach it to your entry via the "Add Attachments, Videos, or Links to This Entry" link above, through which you may also upload a copy of your video. If you are submitting written answers to the questions for this category, provide them in the appropriate spaces below:
- Briefly describe the nominated organization: history and past performance (up to 200 words):
Total 200 words used.
After years of struggling with a debilitating GI disorder, Small Intestinal Bacterial Overgrowth (SIBO), Krystyna Houser, founder of mBIOTA Labs, was introduced to elemental diets, a form of medical nutrition proven effective for a multitude of GI issues. Unfortunately, the existing elemental diets offered were practically undrinkable, leading to extremely low patient compliance rates. Much to her doctor’s surprise, Krystyna completed the unpleasant multi-week challenge, eradicating her SIBO and leaving her determined to find a better way. The average SIBO diagnosis takes six years and it is estimated that 10-15% of the adult US population suffers from some combination of SIBO/IBS. Her commitment to helping the SIBO/IBS community led her to collaborate with the top minds in gastroenterology, nutrition, and food science, bringing them all together in 2021 to create a product that revolutionized elemental diets.
After spending three years developing its flagship formula, the company successfully completed clinical trials at Cedars Sinai LA in November 2023 and launched its primary product, mBIOTA Elemental, in early 2024. With the advent of mBIOTA’s clinically effective and truly palatable diet, doctors now have a therapeutic tool in their “tool kit” that doesn’t require antibiotics, prokinetics or biologics, improving patient options and outcomes.
- Outline the organization's achievements since July 1 2022 that you wish to bring to the judges' attention (up to 250 words):
Total 249 words used.
mBIOTA Elemental delivers a therapeutic tool for health care providers and their patients that was historically almost impossible to utilize. Patients suffering from GI dysfunction live with uncomfortable symptoms that reduce their quality of life. Elemental diets have a clinical track record of helping manage GI disorder, if only their traditionally poor taste was improved so patients could tolerate them.
mBIOTA Elemental is the first and only elemental diet product that successfully achieved this key improvement and is clinically proven. Data from the clinical trial at Cedars-Sinai Los Angeles in November 2023 proved both the ease of diet completion and tolerance.
The study included patients with Small Intestinal Bacterial Overgrowth (SIBO), Intestinal Methanogen Overgrowth (IMO), and a combination of both disorders, with record-breaking results among all therapies:
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100% patient compliance and tolerance for an exclusive two-week series of the orally-ingested diet (this has never been done before)
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100% eradication among SIBO-only patients based on normalization of the lactulose breath test after two weeks
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83% of all patients with SIBO (SIBO-Only and SIBO/IMO combination patients) eradicated with normalization of their lactulose breath test after two weeks
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Patients overwhelmingly preferred mBIOTA Elemental to the market leading competitor across all six organoleptic metrics: taste and aftertaste, smell and consistency, and overall impression and appearance
mBIOTA Labs’s milestone of a 100% completion rate during clinical trial is a remarkable feat, unheard of for elemental diets – it’s no surprise that 100% of patients preferred the taste of mBIOTA Elemental over the leading competitor.
- Reference any attachments of supporting materials throughout this nomination and how they provide evidence of the claims you have made in this nomination (up to 250 words):
Total 187 words used.
mBIOTA Labs Announces Results from First Prospective Clinical Trial of Novel, Palatable Elemental Diet in Patients with SIBO and IMO
This press release announced the initial results of mBIOTA Labs’ clinical trial assessing the efficacy of mBIOTA Elemental and the company’s abstract presentation of the study results at Digestive Disease Week in May 2024. The release provides an overview of the study. It highlights the top takeaways from its results, including its achievement of being the first study with a perfect compliance rate for an orally ingested elemental diet.
mBIOTA Elemental Information Sheet
The mBIOTA Elemental information sheet provides details and key product features, such as ingredients, certifications, and insurance coverage information, along with an overview of its clinical trial completed in November 2023 and topline clinical data results. Additionally, patient testimonials echoing the achievements of this product are included, and a comparison chart of mBIOTA’s product characteristics versus those of its competitors is included.
Elemental Diet and Gut Microbiome Clinical Trial
This study record provides an overview of the mBIOTA Labs’ clinical trial, including a description of the trials, location, study plan, participant criteria, and more.
- Explain why the achievements you have highlighted are unique or significant. If possible compare the achievements to the performance of other players in your industry and/or to the organization's past performance (up to 250 words):
Total 141 words used.
For more than 50 years and across hundreds of clinical studies, doctors and scientists have demonstrated the clinical effectiveness of elemental diets for managing 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 space has seen little to no innovation to solve this challenge since the advent of elemental diets in the 1970s. Yet, over the last couple of years, consumer interest in gut health has gained traction. Whether consumers are suffering from debilitating GI conditions or understanding more about the function and importance of the gut microbiome, more individuals want to take charge of their gut health. Now, they have access to a certified medical food backed by science and clinically proven to support their journey to feeling better, thanks to mBIOTA Labs.
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