Compliance, Safety, and Effect of Exclusive Palatable Elemental Diet in Microbial Overgrowth

Presented at DDW 2024 | Read the full study

Overview

A prospective clinical trial evaluating the mBIOTA Elemental™ diet in adults diagnosed with Small Intestinal Bacterial Overgrowth (SIBO) and/or Intestinal Methanogen Overgrowth (IMO). Participants completed one week of screening, two weeks on an exclusive mBIOTA diet, then two weeks of regular diet reintroduction. The study assessed compliance, safety, gut microbiome changes, breath test normalization, symptoms, and adverse events to determine how an orally‑ingested palatable elemental regimen performs in this population. 

Results

All 30 enrolled subjects tolerated the mBIOTA diet and completed the full course, representing an exceptionally high compliance rate for a complete nutrition protocol. Breath testing showed significant reductions in methane and hydrogen levels, with 73% of participants normalizing their breath tests by the end of the follow‑up phase. The abundance of Methanobrevibacter smithii — a key methane‑producing organism — decreased and correlated with methane levels. Additionally, 83% of subjects reported adequate global relief of GI symptoms. No serious or severe adverse events were observed, indicating a favorable safety profile. 

Conclusions

The findings demonstrate that the mBIOTA Elemental diet is safe and well‑tolerated in adults with SIBO and/or IMO. It produced meaningful physiological changes — including breath test normalization and symptom relief — and was completed by every participant, addressing a historic barrier to elemental diet use. By achieving complete patient adherence and strong microbiome outcomes, the diet addresses a longstanding challenge in GI care—making elemental therapy approachable without sacrificing efficacy. The findings suggest mBIOTA Elemental could transform management of microbial overgrowth, offering gastroenterologists a powerful tool to support gut health and symptom relief in patients who previously struggled with traditional elemental diets.