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The role of the binary toxin in the pathogenesis of C. difficile is unclear.
Given these limitations of genetic detection for binary toxin CDT, there is a clinical need for detection of binary toxin in the stool of patients with CDI.
Binary toxin positive strains that produced neither toxins A and B were investigated in the rabbit ileal loop model to elucidate the contribution of binary toxin in the pathogenesis of CDI (27 ).
On the basis of these observations, which showed a similar case-fatality pattern for the groups that possessed the genes for the binary toxin, in the regression analysis, we combined these 2 groups with the genes for the binary toxin (CD027 and CD non-027) into 1 group, and compared it with the group not possessing the binary toxin (CD A and B).
The role of binary toxin in the pathogenesis of C. difficile remains unclear; however, the presence of this toxin among BI/NAP1/027 epidemic strains has raised concerns about its synergism with toxins A and B in causing severe colitis [ 10].
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It is apparent that the 42- and 51-kDa toxin proteins in local strains have high levels of similarity when matched with protein in binary toxins in the database.
One recent example is the emergence of a hypervirulent strain of Clostridium difficile that produces a newly identified toxin (binary toxin) in addition to the cytotoxins that allow the pathogen to invade intestinal epithelial cells.
We found that the case-fatality rate is highest after infection with strains that possess genes for the binary toxin in addition to toxins A and B, irrespective of the PCR ribotype.
We therefore consider it likely that the binary toxin in PCR ribotype 027, toxinotype III, strains merely reflects clonal spread of a restricted number of strains.
Several clinical studies suggest an association between the presence of binary toxin in infecting C. difficile strains and increased mortality of the patients.
Although the results of the above study are still preliminary, if confirmed, they suggest significant pathogenic capability of binary toxin in combination with toxins A and B in the hamster model as also shown by Kuehne et al., which could account for the increased mortality and disease severity associated with binary toxin-containing C. difficile strains infecting humans.
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