Press Release

The safety of trehalose as it relates to Clostridium difficile as published in the journal EBioMedicine


Hayashibara Co., Ltd.

The article titled “Clostridium difficile trehalose metabolism variants are common and not associated with adverse patient outcomes when variably present in the same lineage” was published in the journal EBioMedicine ( Hayashibara Co., Ltd., as the manufacturer, would like to provide an assessments of this research and make a statement on the safety of our product, TREHA (trehalose).

This article directly contradicts the contents of the article titled “Dietary trehalose enhances virulence of epidemic Clostridium difficile”, in the journal Nature, published in 2018.

According to the EBioMedicine publication, the contents of the article in Nature misrepresent the actual situation that exists in nature. It is reported, along with detailed supporting data, that there is no association between trehalose and infection epidemics caused by virulent C. difficile strains. Hayashibara believes that this research article further demonstrates the safety of trehalose. The summary of the report content is shown below as a table.

Point of issue Nature, 2018 EBioMedicine, 2019
Are the mutation of trehalose metabolic genomes specific mutations for virulent C. difficile strains? Dietary trehalose may induce the mutations to generate virulent C. difficile strains. Data from previously whole-genome sequenced C. difficile isolates were analyzed. Trehalose metabolism variants are widely distributed and have been stably present within C. difficile for thousands of years.
Are the four-gene trehalose metabolism cluster in virulent C. difficile strains associated with epidemic outbreaks and patient mortality? Since virulent C. difficile strains have the four-gene trehalose metabolism cluster, the possibility of association with epidemic outbreaks was claimed. The four-gene cluster is widely present in strains originating from these patients. There was no association between mortality and the four-gene cluster.
What is the association between the outbreak caused by virulent C. difficile strains and amounts of imported bulk trehalose in the various countries? It was claimed that the outbreak due to epidemic C. difficile strains may be associated with imported bulk trehalose to each region. Bulk trehalose imports in the USA, UK, Germany and the EU were <1 g/capita/year during 2000–2006; any evidence linking the outbreaks and imported bulk trehalose was not found.
How does trehalose supplementation effect virulent C. difficile in the large intestine? (n/a) Trehalose supplementation did not increase the growth of C. difficile when compared with glucose in a clinically-validated gut model. Additionally, the supplementation actually reduced toxin detection to undetectable levels.

Total naturally occurring dietary trehalose intake is approximately 100 g per capita per year. This amount of intake is derived from the consumption figure of mushrooms and honey in the United States, imported bulk trehalose is not included.

Hayashibara Co., Ltd., continues to supply safe and high-quality products. We appreciate your continuous support and patronage of TREHA (trehalose).

●Related Press Release
Hayashibara Co., Ltd. Assessment of the “Nature” article, and statement on the safety of TREHA (trehalose)

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