Clinical Evidence Supporting the Use of Elemental Diet for GI Disorders

Millions of people worldwide suffer from gastrointestinal (GI) disorders that significantly impact their quality of life. Managing these conditions often involves navigating through a maze of restrictive diets, medications, and supplements, all while seeking a solution that offers relief.

Elemental diets have emerged as a clinically-proven option that provides a more natural and effective approach to managing GI distress.

    • 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.

    • 100% Patient Compliance

      100% of trial participants made it to the end, finishing two weeks of exclusive mBIOTA Elemental™. 

      This has never been accomplished by any other elemental diet product in a clinical trial setting.

    • 83% Reported Significant Symptom Improvement

      Of equal importance, beyond bacterial eradication, more than 80% experienced symptom improvement and reported feeling better

    Clinically Effective Symptom Reduction

    Trial participants on average reported up to a 65% improvement in symptom severity across 12 common GI symptoms

    When researchers followed up two weeks after the mBIOTA Elemental™ diet was completed, trial participants continued to show improved symptoms and sustained bacterial eradication.

    Try mBIOTA Elemental™
      1. Elemental Diet and Gut Microbiome. Clinicaltrials.gov: NCT05978973. 2023. https://clinicaltrials.gov/study/NCT05978973
      • Irritable Bowel Syndrome (IBS) and SIBO

        Studies have shown that elemental diets can significantly reduce bacterial overgrowth in the small intestine. A landmark study published in the American Journal of Gastroenterology found that an elemental diet resulted in a 75% eradication rate of SIBO, providing substantial symptom relief for patients​. Another retrospective study by Pimentel et al. found that an elemental diet normalized breath tests in 80% of patients with SIBO after 14 days​.

      • Crohn's Disease

        Elemental diets have been validated as effective in inducing and maintaining remission in Crohn's disease. A study in the Journal of Parenteral and Enteral Nutrition concluded that elemental diets are comparably efficacious to corticosteroids in inducing remission, with a more favorable side effect profile​.

      • Eosinophilic Esophagitis (EoE)

        Elemental diets are highly efficacious in managing EoE, an allergic inflammatory condition of the esophagus. Clinical trials have consistently shown significant symptomatic improvement and histologic remission in patients adhering to an elemental diet​.

      • Celiac Disease and Dermatitis Herpetiformis

        In one study, patients who completed four weeks of exclusive elemental diet showed clinical improvement on par with a gluten free diet. Another study found that 100% of patients saw histologic improvement after two weeks of exclusive elemental diet, including alleviated skin rashes. 

      • Acute and Chronic Pancreatitis

        Studies show that elemental diets are a viable alternative for patients with acute pancreatitis who cannot tolerate a regular diet and are not  suitable for tube feeding. 

        For those with chronic pancreatitis, one prospective cohort study found that even a partial elemental diet supplementation resulted in complete pain resolution in 59% of patients, and pain improvement in 29%.

      • Other GI Disorders

        Elemental diets have also proven effective in managing irritable bowel syndrome (IBS), short bowel syndrome, specific food allergies, Eosinophilic Gastritis/Gastroenteritis (EGID), Intestinal Lymphangiectasia, Bile Acid Diarrhea, and prevention of Chemoradiation-Induced Oral Mucositis. The elemental diet mitigates inflammation, promotes mucosal healing, and enhances overall digestive health.

        References: Pimentel, M., et al. (2004). "Normalization of breath testing correlates with symptom improvement in irritable bowel syndrome: a double-blind, randomized, placebo-controlled study." The American Journal of Gastroenterology, 99(4), 658-662. Riordan, A. M., et al. (1993). "A randomized trial comparing elemental diet and corticosteroids in the treatment of active Crohn's disease." Journal of Parenteral and Enteral Nutrition, 17(3), 224-228. Kagalwalla, A. F., et al. (2006). "Effect of six-food elimination diet on clinical and histologic outcomes in eosinophilic esophagitis." Clinical Gastroenterology and Hepatology, 4(9), 1097-1102. Kadunce, D.P., et al., 1991. Published in: Journal of Investigative Dermatology Russell, R.I., et al., 1979. Published in: Digestion Endo, A., et al., 2018. Published in: Annals of Intensive Care Ikeura, T., et al., 2014. Published in: International Journal of Chronic Diseases Nasser, J., Mehravar, S., Pimentel, M. et al. Elemental Diet as a Therapeutic Modality: A Comprehensive Review. Dig Dis Sci (2024). https://doi.org/10.1007/s10620-024-08543-1

        Better Taste. Better Results.

        A truly palatable Elemental Diet is finally here.