Clostridium difficile infection, which can affect the digestive system, is most common in older people and/or those have been treated with antibiotics, which can upset the balance of bacteria in the gut.
The infection which can be passed from person-to-person has been noted as a particular problem in hospitals and care homes where vulnerable groups often taking antibiotics are grouped together. While the condition may be treated with certain antibiotics, relapse is common.
According to the US researchers behind the upcoming pilot study, the pathogen was “of rapidly increasing public health importance”, with the US Centres for Disease Control and Prevention (CDC) calling it one of three “urgent threat” pathogens along with carbapenem antibiotic-resistant Enterobacteriaceae (CRE) and drug-resistant gonorrhoea.
There are an estimated quarter of a million Clostridium difficile infections in the US annually – about 14,000 cases of which are fatal. Meanwhile in Europe a 2009 report from the European Centre for Disease Prevention and Control (ECDC) found an average incidence of 4.1 per 10,000 patient-days per hospital, almost 70% higher than that reported in a 2005 report.
Symptoms of the infection include diarrhea, fever and painful abdominal cramps. It can also lead to life-threatening complications such as toxic megacolon – severe swelling of the bowel from a build-up of gas – and in some serious cases surgery to remove the damaged section of the bowel may be needed.
“Clostridium difficile related deaths have risen 400% over the last decade, and current standard antibiotic treatments are only 75 to 85% successful. Besides increasing the risk of antibiotic resistance and side effects, these treatments are very expensive,” they wrote in the journal Contemporary Clinical Trials.
Instead the University of Wisconsin, University of Virginia and the William S. Middleton Memorial Veterans Affairs Hospital proposed a combination of the probiotic strains L. acidophilus, L. paracasei, B. lactis and B. lactis as an alternative treatment.
The clinical trial will evaluate the effect of four weeks of probiotic therapy in addition to standard care on Clostridium difficile diarrhoea duration and recurrence.
While the numbers for the study were yet to be confirmed, the University of Wisconsin Hospital has a capacity of 536 beds. The recruitment goal over a two-year period was 58 patients. This was hoped to form the basis for a larger study later.
The initial pilot study will look at whether the probiotics can reduce the density of C. difficile toxin in stool, stool cytokines, and fecal lactoferrin, as well as improve patients’ ability to recover.
“Ultimately, this study will produce data, methods, and tools that have widespread relevance and portability, and have the potential to reduce healthcare associated infections.”
Source: Contemporary Clinical Trials
Published online ahead of print, doi:10.1016/j.cct.2015.07.015
“Probiotics for Clostridium difficile infection in adults (PICO): Study protocol for a double-blind, randomized controlled trial”
Authors: A. Barker, M. Duster, S. Valentine, L. Archbald-Pannone, R. Guerrant, N. Safdar