How Krystyna Houser invented the elemental diet through mBIOTA’s proprietary formula

Krystyna Houser spent years battling gastrointestinal (GI) disorders while trying everything she could to heal her body. After successfully treating them through a combination of medical nutrition known as the Elemental Diet (ED) and a dietary protocol, the Low Fermentation Food, Houser became a believer in the power of functional nutrition. Although the Elemental Diet has a low adherence rate due to its strict protocol and unpleasant taste, Houser knew she had to find a way to bring this clinically studied solution to the millions of people who suffer from GI ailments every day. .

“Elemental diets gave me my life back, but that journey was a difficult one. My husband once mixed me a shake and threw up just smelling it, so that should give you some perspective. The diet worked, but it made a difficult situation even more difficult and I knew there had to be a better way. As I endured several rounds of non-drinking elemental diets to treat my SIBO, I began dreaming of getting the best minds in the room to create a new formula that would taste better and convince doctors that it’s a workable treatment protocol. People said it would be extremely difficult, but I knew that if we could remove the terrible taste barrier, it would be life-changing, and it already is,” she shared of her first-hand 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 complete nutritional liquid formulas composed of predigested nutrients (amino acids, simple carbohydrates, fats, vitamins and minerals), which allow rapid absorption in the upper GI tract. This minimizes the digestive burden, giving the gut mucosa and gut microbiome a chance to recover. Additionally, EDs have anti-inflammatory effects. Furthermore, they have no food allergens as their protein source is only through free amino acids, which are non-allergenic. In some studies, however, up to 40% of patients were unable to tolerate oral administration due to its taste. Which was the main catalyst in Houser seeking to find a better solution to the Elemental Diet.

Houser joined Dr. Mark Pimentel and Dr. Ali Rezaie to bring to life the concept of an enjoyable elementary diet. “The actual research and development took three years, but from concept to launch it took about eight or nine years. When I first did the elemental diet, I would dream of a good tasting formula almost like a fantasy. Then one day I decided to gather a team of scientists and doctors to put it into play and see if it was really achievable. Despite many naysayers, we decided it might be possible and got to work,” Houser explained. “Developing the flavor profile and figuring out how to handle the amino acids was the hardest part. Most of the essential amino acids have a pretty terrible taste, so we had to develop our own proprietary blend and method to combat that. We found some amazing food scientists and were able to use the latest technology to taste to solve our amino acid puzzle. It was definitely the most challenging part, but then again, if it was easy to do, they would have made the elemental diets taste good the first time.”

The Elemental Diet has been studied and proven to treat SIBO and IMO, but there hasn’t been much innovation in over 40 years. Houser thinks this is because GI issues disproportionately affect women, which tend to be overlooked across the board in health care. Additionally, SIBO wasn’t even officially recognized as a disease condition until 2023 after mBIOTA’s Dr. Ali Rezaie, pressured her to get her own diagnostic code. It is only very recently that people have recognized the widespread prevalence of SIBO and how many of them suffer from a previously unknown, treatable disease. “I also don’t think it ever occurred to anyone that people would do a two-week protocol on taking a pill, even if it might lead to better results. The industry underestimates how much pain bowel patients suffer and what we are willing to do to eliminate our symptoms and get some relief. The protocol can really do wonders,” she added.

Since launching in 2024, mBIOTA Elemental™ has been able to address historical issues with Elemental Diets: poor palatability and patient compliance. After three years of research and development, the formulation was completed and clinically tested at Cedars Sinai Los Angeles. Designed for the dietary management of patients with Gl dysfunction, mBIOTA’s highly palatable elemental diet offers complete nutrition, providing essential nutrients, vitamins and minerals in an easily absorbable formula in either orange or an original vanilla flavor.

With the taste problem solved with mBIOTA’s Elemental Diet, the team was able to complete a two-week clinical trial with 100% patient compliance. 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 antibiotic efficacy for SIBO and IMO hovers around 50% or less, the 2023 clinical trial at Cedars-Sinai using mBIOTA Elemental™ showed an 83% success rate in eradicating SIBO overall. Additionally, 83% of participants experienced symptom improvement and up to 65% improvement in the 12 most common GI symptoms. Patients were tested with a lactulose test before and after two weeks of mBIOTA adherence. “The suggested protocol involves exclusive use of mBIOTA for a specified period (eg, 2-4 weeks), followed by a gradual reintroduction of regular foods. Chronic conditions may require longer duration or repeated courses for maintenance, depending on severity and response,” explained Dr. Rezaie.

“For many people, it has been life-changing, and not just among SIBO patients. Some of our Crohn’s patients have seen dramatic changes in their lifestyle, and it has made it all worth it. It has been a privilege to see our clients move from years of worry, pain and frustration to enjoying life again. On the practitioner side, it’s really exciting to see doctors and nutritionists embrace the product. Most of them remember the rudimentary diets from medical school, but they also remember how unpopular they once were, to the point where they were essentially unusable. So for them to see now that this is a viable tool again for both induction and maintenance of remission is beyond exciting. The collaboration and development of mBIOTA Elemental has been the most significant achievement of my professional career,” said Houser. “In some ways, the highest praise for our formula is evident in how many of our customers come back for more. Chronically ill patients use our shakes for meal replacement when traveling and for tuning in when they’re feeling tired or experiencing a flare-up. It has really become a reliable tool in their maintenance phase.”

Another interesting finding from the clinical trial that was recently discovered is the reduction of visceral fat. An average reduction in body weight of 5% in the fourth week and a sustained reduction of 4% in the fourth week. Visceral fat area decreased by 9.6% in the second week and continued to decrease, reaching an 11.2% reduction in the fourth week, and total body fat decreased significantly, while only a minimal reduction in lean mass was observed. bodily. Notably, fat loss persisted even after participants resumed their regular diets, indicating the potential for this elemental diet to induce lasting changes in body composition. The implications of this study are particularly important as it suggests that the mBIOTA Elemental™ diet may support non-sarcopenic fat loss, a promising avenue for future research into the metabolic and hormonal mechanisms underlying this sustained weight reduction.

Multiple trials are underway using mBIOTA for irritable bowel syndrome (IBS): Evaluating efficacy in symptom management Food allergies: Exploring its role in elimination diets Metabolic disorders: Investigating potential benefits for conditions such as metabolic syndrome and weight loss and Crohn’s disease: evaluate the efficacy of diet in reducing symptoms and endoscopic ulcerations. “As multiple clinical trials are being planned, but according to our experience with previous clinical trials with elemental diets. Several groups of patients can potentially benefit: Endosinophilic gastroenteritis: Reduction of eosinophilic infiltration and symptoms, Chronic pancreatitis: Nutritional support and pain relief, Food intolerance, Celiac disease refractory to a gluten-free diet, Crohn’s disease, Ulcerative colitis, Esophilic arthritis, artesophilic , weight management and reduction of body fat”, added Dr. Rezaie.

Now that mBIOTA is becoming popular among doctors and practitioners, Houser is on a mission to identify even more opportunities and use cases with the proprietary formula. “We are still interpreting the findings of our clinical trial at Cedars-Sinai and are excited to move into other areas of health and wellness based on what we have learned. Right now, we’re working on a gut reset for anyone who wants to improve their GI function, and we see exciting potential for using the elemental diet as a supplement for people taking GLP-1 for weight loss or those who experience GI problems as a result of their GLP-1 use,” Houser said.

mBiota is a medical grade food and intended to be supervised by a physician during its use.