NICD warns of A. clausii bacteraemia outbreak linked to probiotic

The National Institute for Communicable Diseases (NICD) has identified an outbreak of Alkalihalobacillus clausii (A. clausii) bacteraemia linked to the use of the Enterogermina probiotic in private hospitals in Gauteng and North West.  

Since January 2024, 11 cases of the A. clausii bacteraemia have been identified in eight hospitals in Gauteng and North West.  

The NICD said the outbreak was flagged on June 11 by a pathologist from a private laboratory, prompting an in-depth investigation.

According to the NICD, microbiological records of A. clausii-positive blood cultures were collected from the reporting laboratory from January to October.  

“Most of the patients had reported using Enterogermina probiotics before the bacteraemia onset. Isolates from four cases and two open packets of Enterogermina probiotic used by the patients were sent to the NICD for whole genome sequencing,” it said.

According to NICD, the investigation determined Enterogermina probiotic as the likely source for A. clausii bacteraemia.

A. clausii is a non-pathogenic spore-forming Gram-positive bacillus, which has demonstrated probiotic properties and significant therapeutic potential. It is commonly prescribed to manage gut dysbiosis and diarrhoea, including antibiotic-associated diarrhoea, by suppressing pathogenic bacteria and promoting anti-inflammatory responses. 

This species has been used in oral bacteriotherapy products such as Enterogermina. It is safe for most populations, including children and immunocompromised individuals, though caution is needed in severely immunocompromised patients.

The NICD said it shared a detailed report with the reporting laboratory recommending that all pharmacists at hospitals with A. clausii bacteraemia cases notify the South African Health Products Regulatory Authority for further investigation.

“Hospitals with cases clustering by time and place should conduct further investigations to rule out a healthcare associated source. Healthcare professionals and patients should be informed of this outbreak and educated on the safe use of probiotics including consideration of patients' immune status, contraindications and side effects,” said the NICD.

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