Efficacy of Consuming LcS In Spinal cord injury Patients (ECLISP)
Research type
Research Study
Full title
Effect of Lactobacillus casei Shirota in preventing antibiotic associated diarrhoea (AAD) including Clostridium difficile associated diarrhoea (CDAD) in patients with spinal cord injuries: a multicentre, randomised, double-blind, placebo-controlled trial
IRAS ID
158527
Contact name
Samford Wong
Contact email
Sponsor organisation
Buckinghamshire Healthcare NHS Trust
Research summary
Probiotics, defined as ‘live microorganisms which, when administered in adequate amounts, confer a health benefit on the host’, have been proposed to help maintain a healthy gut microbiota in hospitalised patients on antibiotic therapy, particularly those on broad spectrum antibiotics. It is hypothesised that maintenance of a healthy commensal microbiota during antibiotic treatment by administration of a daily probiotic (Lactobacillus casei Shirota, as Yakult) will significantly reduce the occurrence of AAD and CDAD, and thus improve quality of life in spinal cord injury patients over time in comparison to the placebo control. A previous trial in patients with spinal cord injuries (SCI) suggests that a probiotic preparation (Lactobacillus casei Shirota: LcS) can prevent antibiotic associated diarrhoea (AAD) (54.9% v 17.1%) (Wong et al, 2014).
Apart from the above open-labelled study conducted at NSIC at Stoke Mandeville Hospital, other studies have reported Yakult effectiveness in reducing antibiotic-associated diarrhoea. Our previous study conducted in Stoke Mandeville showed that one bottle of Yakult during antibiotics and for one week after the medication ceased, was significantly effective in reducing incidence of AAD. However, in order to confirm these effects and fully demonstrate the extent of LcS effectiveness in these patients, a larger placebo-controlled study including different geographical locations is indicated.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
14/SC/1101
Date of REC Opinion
4 Aug 2014
REC opinion
Further Information Favourable Opinion