Company: mBIOTA Labs, Santa Monica, CA
Nomination Submitted by: Matter Health
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 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 in length about the achievements of the nominated organization since January 1 2023, OR written answers to the questions for this category? (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 nominated 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 providing written answers for your submission, you must provide an answer to this first question: Briefly describe the nominated organization: its history and past performance (up to 200 words):
Total 198 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. To her doctor’s surprise, Krystyna completed the multi-week challenge, eradicating her SIBO and leaving her determined to find a better way. With concerning statistics such as 10-15% of the adult US population suffering from some combination of SIBO/IBS and low diagnoses rates, Krystyna assembled the top minds in gastroenterology, nutrition, and food science to create a product that revolutionized elemental diets.
mBIOTA Labs aimed to develop a “palatable” elemental diet while still remaining fully elemental. After spending three years developing its flagship formula, the company successfully completed clinical trials at Cedars Sinai in November 2023, launched mBIOTA Elemental™ online in 2024 and expanded to international shipping within six months. mBIOTA Elemental™ is the first and only elemental diet that has successfully developed a clinically-proven palatable formula. This medical-grade product is directly available to consumers and trusted by hundreds of referring healthcare specialists and dietitians.
- If you are providing written answers for your submission, you must provide an answer to this second question: Outline the organization's achievements since the beginning of 2023 that you wish to bring to the judges' attention (up to 250 words):
Total 233 words used.
Patients suffering from GI dysfunction live with uncomfortable symptoms that diminishes their quality of life. Elemental diets have a clinical track record of helping manage GI disorders, but were infamously avoided due to their traditionally intolerable taste. mBIOTA Elemental™ is the first and only elemental diet that has successfully developed a clinically-proven palatable formula, trusted by healthcare specialists and dietitians, that is also directly available to consumers.
The international availability of the product and free online food transition guide underscores their commitment to reducing barriers for effective dietary management of gastrointestinal (often chronic or recurring) dysfunction while supporting providers who have little time or resources to support patients post-diet. These initiatives reinforce mBIOTA’s determination to increase resource accessibility and GI health education in international markets where elemental diets options are severely limited.
Data from mBIOTA’s clinical trial at Cedars-Sinai 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 patient groups:
- 100% patient compliance and tolerance for an exclusive two-week series of the orally-ingested diet (this has never been done before)
- 100% eradication among SIBO-only patients based on normalization of the lactulose breath test after two weeks
- 83% of all patients with SIBO (SIBO-only and SIBO/IMO combination patients) eradicated with normalization of their lactulose breath test after two weeks
- If you are providing written answers for your submission, you must provide an answer to this third question: 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 248 words used.
Across hundreds of clinical studies and 50+ years, scientists have demonstrated the clinical effectiveness of elemental diets for managing a wide range of gastrointestinal diseases. However, the infrequent use of element diets – resulting from the traditionally unpalatable taste and poor patient compliance – has left the space with little interest and no innovation. But with growing consumer focus on gut health and more individuals wanting to take charge of their health journeys has reinforced the need for a better option. Now, consumers have direct access to a clinically proven medical food that tastes good and supports their journey to relief of often debilitating symptoms. No other elemental diet or medical food company has accomplished innovation since the category began.
The certified medical food industry is highly restrictive, contributing to it being historically a silent category. However, as healthcare and consumer demands increasingly overlap, mBIOTA’s momentum has the potential to be a needed driver for more nutrition-forward methods.
Providers are also interested in incorporating mBIOTA Elemental™ into their GI management protocols. Typically within hospital systems, competitor elemental diet brands may only be reserved for patients in comas or otherwise physically unable to eat, and antibiotics are the first recommendation for patients enduring severe GI symptoms, yet many patients may prefer to avoid harsh medications or find their bodies rejecting antibiotics altogether. Now with a clinically proven palatable option at their disposal, over 1,000 healthcare practitioners across the country are actively engaging with, sampling, and recommending mBIOTA Elemental™.
- You have the option to answer this final question: 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 248 words used.
- Clinical Evidence Supporting the Use of Elemental Diet for GI Disorders
- This page on mBIOTA’s website breaks down the initial results of mBIOTA Labs’ clinical trial assessing the efficacy of mBIOTA Elemental™,the company’s abstract presentation of the study results at Digestive Disease Week in May 2024, and further clinical evidence for the use of elemental diets for a span of GI disorders.
- mBIOTA Elemental Information Sheet
- The mBIOTA Elemental™ information sheet provides details and key product features, along with an overview of its topline clinical data results. Additionally, patient testimonials and a comparison chart of mBIOTA’s product versus its competitors’ are 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.
- mBIOTA Elemental Patient Stories and Customer Testimonials
- This website page highlights Manuela, an mBIOTA Elemental™ patient, and her personal struggles in gut symptom management before discovering mBIOTA Elemental™, from her prior hesitations to her ultimate symptom management relief. This page additionally features customer reviews and testimonials telling their own experiences and tips with completing the elemental diet.
- Food Transition Guide
- Developed in with GI and nutrition specialists, the mBIOTA Labs Food Transition Plan is a free, digitally accessible seven-day transition food guide full of tips and recipes to help anyone reintroduce their bodies to solid foods after completing an elemental diet while sustaining balance within their gut microbiome and preventing future GI flare-ups.
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