Effect, Tolerability, and Safety of Exclusive Palatable Elemental Diet in Patients With Intestinal Microbial Overgrowth

Published in Clinical Gastroenterology and Hepatology | Read the full publication

Overview

Elemental diets are liquid formulas composed of pre-digested nutrients that are easily absorbed, historically used for gut disorders but limited by poor taste and low patient adherence. This trial was designed to test whether making such a diet more palatable could improve tolerance, microbial outcomes, and symptom relief in adults diagnosed with SIBO and/or IMO. 

Results

30 adult participants completed a two-week exclusive course of mBIOTA followed by a two-week regular diet reintroduction period.

• Tolerance and safety: all enrolled subjects completed the diet with no serious or severe adverse events.
• Microbiome analysis showed significant changes after mBIOTA, including decreased relative abundance of Prevotella_9 and Fusobacterium, while levels of the methane-producing organism Methanobrevibacter smithii were reduced and correlated with lower breath methane levels. 
• Average methane and hydrogen levels dropped significantly, and 73% of participants normalized their lactulose breath tests
• Symptom relief was reported by 83% of subjects, indicating meaningful improvements in bloating, distention, abdominal discomfort, and other common symptoms. 

These findings suggest that enhancing palatability can boost adherence and clinical benefit in dietary interventions for gut microbial imbalance. 

Conclusion

This study provides promising evidence that mBIOTA is a safe, tolerable, and potentially effective non-antibiotic approach for managing SIBO and IMO. By making elemental formulas more acceptable to patients, high completion rates and measurable improvements in both objective breath test outcomes and subjective symptom relief were achieved.