For Clinicians
mBIOTA Elemental — For Clinicians
A non-pharmacologic intervention
built on rigorous science.
Elemental nutrition designed for real-world clinical practice, with the compliance data, institutional partnerships, and patient support infrastructure to match.
THE OVERVIEW
Elemental Diet Overview
Elemental diets are nutritionally complete liquid medical formulas that provide macronutrients in their simplest, pre-digested forms: free amino acids, simple carbohydrates (typically maltodextrins), and primarily medium-chain triglycerides (MCTs), along with essential vitamins and minerals. By eliminating intact proteins and complex macronutrients, these formulas require minimal gastric, pancreatic, and brush-border enzymatic activity. Nutrients are absorbed largely in the proximal small intestine, thereby limiting exposure of distal, often inflamed bowel to luminal antigens and digestive workload.
HOW IT WORKS
Mechanism of Action
Mechanism 01
Immune Modulation
The therapeutic effects of elemental diets are multifactorial. First, they reduce antigenic load. Because protein is provided as free-form amino acids rather than intact proteins, mucosal immune stimulation is minimized—an important consideration in disorders such as eosinophilic esophagitis and inflammatory bowel disease.
Mechanism 02
Microbial / Fermentation Control
Second, elemental diets remove fermentable substrates from the small intestine. By delivering rapidly absorbable carbohydrates and excluding fiber and complex macronutrients, they deprive overgrown bacteria of fuel. This reduces fermentation, gas production, and luminal inflammatory signaling—particularly relevant in small intestinal bacterial overgrowth (SIBO).
Mechanism 03
Pancreatic & Digestive Rest
Third, their low-fat, MCT-predominant composition decreases cholecystokinin-mediated pancreatic stimulation, which is clinically useful in acute and chronic pancreatitis.
Mechanism 04
Microbiome Modulation & Gut Barrier Support
Importantly, elemental diets also promote microbiome modulation. Rather than broadly eradicating microbes, available data suggest targeted shifts in microbial composition consistent with decreased substrate-driven overgrowth. In parallel, certain amino acids—particularly glutamine—may support epithelial integrity and tight junction function, contributing to improved barrier health.
Clinical Rationale
Clinically, elemental diets function as metabolically supported bowel rest: they reduce mechanical, enzymatic, microbial, and antigenic stress while maintaining full nutritional adequacy. Exclusive protocols are typically implemented for 2–4 weeks, with partial regimens used selectively based on indication and patient tolerance.
Evidence supports their application in small intestinal bacterial overgrowth, Crohn’s disease, eosinophilic esophagitis, pancreatitis, malabsorption states, post-surgical recovery, and selected autoimmune or inflammatory conditions. For physicians, elemental diets represent a mechanistically coherent, non-pharmacologic intervention that addresses luminal drivers of inflammation and dysbiosis while preserving nutritional status. When used in appropriately selected patients and under clinical supervision, they can serve as a therapeutic bridge—facilitating symptom control, mucosal healing, and in some cases, reduction in medication burden.
THE SCIENCE
Clinical Pipeline
mBIOTA is deeply committed to advancing clinical nutrition through rigorous, collaborative research. We believe elemental diets represent a powerful, evidence-based therapeutic modality and that we are only beginning to define their full potential in the management of disease.
We actively partner with leading clinicians, investigators, and academic research institutions to design and execute rigorous clinical trials. Our portfolio spans from translational research to clinical interventional and outcomes-based studies. Through high-quality clinical research, we aim to deepen understanding of how these interventions can be optimized in practice—ultimately improving patient experience, expanding therapeutic options, and delivering better clinical outcomes.
Our current pipeline includes more than 10 ongoing and planned trials across multiple indications, reflecting our sustained investment in furthering scientific research. We are committed to transparent collaboration and welcome opportunities to work with investigators who share our focus on advancing standards of care.
In addition to our trial activity, our team regularly engages with the broader scientific community through participation in major medical congresses, including Digestive Disease Week and the American College of Gastroenterology Annual Scientific Meeting. These engagements ensure that our research priorities remain aligned with emerging data, evolving clinical needs, and the shared goal of improving patient outcomes.
Clinical Data & Research
mBIOTA Elemental™ has been published in peer-reviewed literature, with our landmark compliance study appearing in Clinical Gastroenterology and Hepatology (CGH)—the official journal of the American Gastroenterological Association. Our research portfolio spans translational, interventional, and outcomes-based studies conducted in collaboration with leading academic institutions.
100%
Patient compliance in the CGH Cedars-Sinai trial — a first in elemental diet research
10+
Ongoing and planned clinical trials across multiple indications
5+
Major congress abstracts presented at DDW and ACG
PATIENT COMPLIANCE
Adherence Like Never Before
100%
First-ever full compliance in elemental diet research
One of the biggest barriers to elemental diets has always been poor palatability and low adherence. mBIOTA Elemental changed that. In a 2023 Cedars-Sinai study published in the peer-reviewed journal Clinical Gastroenterology and Hepatology (CGH), the formula achieved 100% patient compliance—something never before seen in elemental diet research. This reflects meaningful advances in taste, tolerability, and real-world usability.
We also support adherence beyond the formula itself. mBIOTA is built around patient experience, providing patient education materials, webinars with product experts, preparation guidance, and structured resources to help individuals complete the protocol and reintroduce solid food.
We support physician offices with practical tools such as Letter of Medical Necessity (LMN) templates and reimbursement guidance to streamline workflow. Our team is also available to provide educational sessions for clinicians and office staff on elemental diets and appropriate use of mBIOTA Elemental.
Coverage & Access
Insurance Coverage
mBIOTA Elemental™ has successfully been reimbursed through many insurance plans when submitted with appropriate documentation and medical necessity. While coverage varies by carrier and plan, our team provides guidance to help patients navigate reimbursement and submit claims.
In addition, HSA and FSA funds can be used at checkout, making access more flexible for patients.
Resources
Downloads & Resources
- ↓ Clinical Gastroenterology and Hepatology Publication
- ↓ Elemental Diets as a Therapeutic Modality: A Comprehensive Review
- ↓ Clinical Data Summary
- ↓ Clinical Protocol Summary
- ↓ Nutrition Fact Sheet
- ↓ DDW 2024 Abstract: Elemental Diets and SIBO/IMO
- ↓ ACG 2024 Abstract: Organoleptic Acceptability
- ↓ FNM 2024 Abstract: Visceral Fat and Muscle Mass
- ↓ DDW 2025 Abstract: M. smithii Reduction
- ↓ ACG 2025 Abstract: Visceral Fat Loss and Microbial/Hormonal Link
- ↓ ACG 2025 Abstract: Partial Small Bowel Obstruction
- ↓ ACG 2025 Abstract: Eosinophilic Esophagitis
- ↓ ACG 2025 Abstract: Fungal Overgrowth and Candida
- ↓ Digestive Diseases and Sciences: Partial Small Bowel Obstruction
Clinician FAQs
Have questions about using mBIOTA Elemental?
We've compiled commonly asked questions from practitioners, for practitioners. Whether it's about elemental diet protocols, reimbursement, or patient selection criteria—answers are waiting for you.
We're Here for Your Practice
mBIOTA offers dedicated support for clinicians and their teams.
We host provider-focused webinars covering clinical protocols, research updates, and case-based implementation strategies. Our clinical support team and nurse navigators are available via chat, phone, and email to answer product, protocol, or reimbursement questions in real time. We also offer 1:1 meetings for personalized discussion of patient cases or practice integration, ensuring your team feels confident using elemental nutrition in clinical care.
Clinician Sample Request
Request Product Samples
If you are a healthcare professional and are interested in learning more about mBIOTA Elemental™, or receiving product samples for your practice, please fill out the form below and a member of our sales team will be in touch.
