Krystyna Houser spent years battling gastrointestinal (GI) disorders trying everything she could to heal her body. After successfully treating them through a combination of medical food known as the Elemental Diet (ED), and a dietary protocol, Low Fermentation Eating, Houser became a believer in the power of functional nutrition. Although the Elemental Diet has a low adherence rate due to its stringent protocol and unpleasant taste, Houser knew she needed to find a way to bring this clinically studied solution to millions of people who suffer from GI conditions daily.
“Elemental diets gave me my life back but that journey was a hard road. My husband once mixed a shake for me and vomited just by smelling it, so that should give you some perspective. The diet worked, but it made a hard situation even harder, and I knew there had to be a better way. As I suffered through several rounds of undrinkable elemental diets to treat my SIBO, I started to dream about getting the best minds in the room to create a new formula that would taste better and convince doctors that it is a viable treatment protocol. People said it would be extremely difficult but I knew that if we could actually remove the awful taste barrier it would change lives, and it has already,” she shared about her firsthand experience with the Elemental Diet.
The Elemental Diet is traditionally used to manage gastrointestinal (GI) disorders such as Crohn’s disease, eosinophilic esophagitis, severe food allergies and small intestinal bacterial overgrowth (SIBO). They are nutritionally complete liquid formulas composed of pre-digested nutrients (amino acids, simple carbohydrates, fats, vitamins, and minerals), which allow for rapid absorption in the upper GI tract. This minimizes the digestive workload, giving the gut mucosa and gut microbiome a chance to restore. Moreover, ED’s possess anti-inflammatory effects. Additionally, they are devoid of food allergens as their source of proteins is only through free amino acids which are not allergenic. In some studies, however, up to 40% of patients were unable to tolerate oral administration due its taste. Which was the major catalyst in Houser looking to find a better solution to the Elemental Diet.
Houser teamed up with Dr. Mark Pimentel and Dr. Ali Rezaie to bring the concept of a palatable Elemental Diet to life. “The actual R&D took three years but from concept to launch it has taken about eight or nine years. When I did the Elemental Diet for the first time, I would daydream about a good-tasting formula almost as a fantasy. Then one day I decided to assemble a team of scientists and doctors to game it out and see if it was actually achievable. Despite a lot of naysayers, we determined that it might be possible, and we got to work,” Houser explained. “Developing the taste profile and figuring out how to address the amino acids was the most difficult part. Most essential amino acids are pretty awful tasting so we needed to develop our own proprietary mix and method to combat this. We found some amazing food scientists and we were able to leverage cutting-edge taste technology to solve our amino acid puzzle. It was definitely the most challenging piece but then again, if it was easy to do, they would have made elemental diets taste good the first time.”
The Elemental Diet has been studied and proven to treat SIBO and IMO but hasn’t had much innovation in over 40 years. Houser thinks this is due to GI issues disproportionately affecting women, who tend to be overlooked across the board in health care. Additionally, SIBO was not even being officially recognized as a disease state until 2023 after mBIOTA’s own, Dr. Ali Rezaie, pushed for it to get its own diagnosis code. It is only very recently that people have recognized the widespread prevalence of SIBO and how many are suffering with a previously unrecognized, treatable disease. “I also don’t think it ever occurred to anyone that people would do a two-week protocol over just taking a pill, even if it might lead to better outcomes. The industry underestimates how much pain gut patients are in, and what we’re willing to do to eradicate our symptoms and get some relief. The protocol can really work wonders,” she added.
Since launching in 2024, mBIOTA Elemental™ has been able to address the historic issues with Elemental Diets: poor taste and patient compliance. After three years of research and development, the formulation was completed and clinically trialed at Cedars Sinai Los Angeles. Designed for the dietary management of patients with Gl dysfunction, mBIOTA’s highly palatable elemental diet provides complete nutrition, delivering essential nutrients, vitamins and minerals in a readily absorbable formula in either orange or an original vanilla tasting flavor.
With the taste issue resolved with mBIOTA’s Elemental Diet, the team was able to complete a two week clinical trial with 100% patient adherence. This had not been done before in previous clinical trials with any Elemental Diet. The trial also found an 83% eradication rate of SIBO. While the efficacy of antibiotics for SIBO and IMO hover around 50% or less, the 2023 clinical trial at Cedars-Sinai using mBIOTA Elemental™ demonstrated a 83% success rate in eradicating SIBO overall. Additionally, 83% of participants experienced symptom inprovement and up to 65% improvement of the 12 most common GI symptoms. Patients were tested with a lactulose test before and after adhering to two weeks of mBIOTA. “The suggested protocol involves exclusive use of mBIOTA for a defined period (e.g., 2–4 weeks), followed by a gradual reintroduction of regular foods. Chronic conditions may require longer durations or repeated courses for maintenance, depending on the severity and response,” explained Dr. Rezaie.
“For many people, it’s been life-changing, and not just among SIBO patients. Some of our Crohn’s patients have seen dramatic changes in their lifestyle, and that has made it all worthwhile. It’s been a privilege to see our customers go from years of discomfort, pain and frustration to enjoying life again. From the practitioner side, it’s really exciting to see doctors and nutritionists embrace the product. Most of them remember elemental diets from medical school but they also remember how truly unpalatable they used to be, so much so they were essentially unusable. So for them to now see that this is a viable tool again for both induction and maintenance of remission is beyond exciting. Collaborating on, and developing, mBIOTA Elemental has been the most meaningful achievement of my professional career,” expressed Houser. “In some ways, the highest praise for our formula is evident in how many of our customers come back for more. Patients with chronic conditions use our shakes for meal replacements when they travel, and for tune-ups when they are feeling off or experiencing a flare. It’s really become a trusted tool in their maintenance phase.”
Another interesting finding from the clinical trial that was more recently reveled is the reduction of visceral fat. A mean reduction in body weight by 5% at week four and a sustained 4% reduction at week four. Visceral fat area decreased by 9.6% at week two and continued to decline, reaching an 11.2% reduction at week four and total body fat decreased significantly, while only a minimal reduction in lean body mass was observed. Notably, the fat loss persisted even after participants resumed their regular diets, indicating the potential for this elemental diet to promote lasting changes in body composition. This study’s implications are particularly relevant as it suggests that the mBIOTA Elemental™ diet could support non-sarcopenic fat loss, a promising avenue for future research into metabolic and hormonal mechanisms underlying this sustained weight reduction.
Multiple trials are under way using mBIOTA for Irritable Bowel Syndrome (IBS): Assessing efficacy in symptom management, Food Allergies: Exploring its role in elimination diets, Metabolic Disorders: Investigating potential benefits for conditions like metabolic syndrome and weight loss and Crohn’s disease: To assess the efficacy of the diet in reducing symptoms and endoscopic ulcerations. “As multiple clinical trials are being planned but as per our experience with prior clinical trials with elemental diets. Several groups of patients can potentially benefit: Endosinophilic Gastroenteritis: Reduction in eosinophilic infiltration and symptoms, Chronic Pancreatitis: Nutritional support and pain alleviation, Food Intolerances, Celiac disease refractory to gluten free diet, Crohn’s disease, Ulcerative Colitis, Eosinophilic Esophagitis, Rheumatoid Arthritis and Weight Management and body fat reduction,” added Dr. Rezaie.
Now that mBIOTA is becoming known amongst doctors and practitioners, Houser is on mission to identify even more possibilities and use cases with the proprietary formula. “We are still interpreting the findings of our clinical trial at Cedars-Sinai and we’re excited to move into other areas of health and wellness based on what we’ve learned. Right now, we’re working on a gut reset for anyone who wants to improve their GI function, and we see some exciting potential for using the elemental diet as supplemental nutrition for people taking GLP-1s for weight loss or for those experiencing GI issues as a result of their GLP-1 use,” Houser said.
mBiota is a medical grade food and meant to be supervised under a practitioner during its use.
