Lactobacillus casei Shirota probiotic drinks reduce antibiotic associated diarrhoea in patients with spinal cord injuries who regularly consume proton pump inhibitors: a subgroup analysis of the ECLISP multicentre RCT.

STUDY DESIGN: This was a sub-group analysis of a multicentre, randomised, placebo-controlled, double-blind trial (ECLISP trial) OBJECTIVES: To assess the efficacy of a probiotic containing at least 6.5 × 109 live Lactobacillus casei Shirota (LcS) in preventing antibiotic associated diarrhoea (AAD) in patients with spinal cord injury (SCI) who consumed proton pump inhibitor (PPI) regularly. LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. The trial was registered with ISRCTN:13119162. SETTING: Three SCI centres (National Spinal Injuries Centre, Midland Centre for Spinal Injuries and Princess Royal Spinal Cord Injuries Centre) in the United Kingdom METHODS: Between November 2014, and November 2019, 95 eligible consenting SCI patients (median age: 57; IQ range: 43-69) were randomly allocated to receive LcS (n = 50) or placebo (n = 45). The primary outcome is the occurrence of AAD up to 30 days after finishing LcS/placebo. RESULTS: The LcS group had a significantly lower incidence of AAD at 30 days after finishing the antibiotic course (28.0 v 53.3%, RR: 95% CI: 0.53, 0.31-0.89; z = 2.5, p = 0.01). Multivariate logistic regression analysis identified that LcS can reduce the risk of AAD at 30 days (OR: 0.36, 95% CI 0.13, 0.99, p < 0.05). No intervention-related adverse events were reported during the study. CONCLUSIONS: LcS has the potential to prevent AAD in what could be considered a defined vulnerable group of SCI patients on regular PPI. A confirmatory, randomised, placebo-controlled study is needed to confirm this apparent therapeutic success to translate it into appropriate clinical outcomes. SPONSORSHIP: Yakult Honsha Co., Ltd.

A study into the effect of Lactobacillus casei Shirota in preventing antibiotic associated diarrhoea including Clostridioides difficile infection in patients with spinal cord injuries: a multicentre randomised, double-blind, placebo-controlled trial.

BACKGROUND: Antibiotic Associated Diarrhoea (AAD) and Clostridioides Difficile Infection (CDI) are of major concern in spinal cord injury (SCI) rehabilitation. METHODS: A multi-centre, randomized, double-blind, placebo-controlled (the ECLISP) trial, was conducted in three tertiary spinal cord injury centre in the UK to assess the efficacy of consuming a probiotic beverage containing at least 6.5 × 109 live Lactobacillus casei Shirota (LcS) in preventing AAD and CDI and in patients with SCI and to determine whether proton pump inhibitors (PPI) and under nutrition-risk are risk factors for AAD/CDI. LcS or placebo was given once daily for the duration of an antibiotic course and continued for 7 days thereafter. Follow up was set at 7 and 30 days after the antibiotic course finished. The primary outcome was occurrence of AAD up to 30 days after finishing LcS/placebo. This trial is completed and registered (ISRCTN:13119162). FINDINGS: Between November 2014, and November 2019, 359 consenting adult SCI patients (median age: 53.3; range: 18-88 years), from 3 SCI centres responsible for providing approximate 45-50% of UK SCI service, with a requirement for antibiotics due to infection were randomly allocated to receive LcS (n = 181) or placebo (n = 178). Overall, no statistical difference was seen in occurrence of the primary outcomes of AAD at 30 days follow up (45% v 42.1%, RR: 1.071, 0.8-1.4, p = 0.639). In the secondary analyses LcS was associated with a lower risk of AAD at 7 (19% v 35.7%, RR: 0.53, 0.29-0.99, p = 0.040) and 30 days follow up (28% v 52.2%, RR: 0.54, 0.32-0.91, p = 0.015) in the participants who took PPI regularly. Under nutrition-risk was associated with an increased risk of AAD at 7 (RR: 1.76, 1.28-2.44) and 30 days follow up (RR: 1.69, 1.30-2.0). No intervention-related adverse events were reported during the study. INTERPRETATION: The present study indicates that LcS could not prevent AAD/CDI in unselected SCI patients. LcS might have the potential to prevent AAD in the higher risk group of patients on regular PPI. Confirmatory studies are needed to allow translation of this apparent therapeutic success into improved clinical outcomes. FUNDING: Yakult Honsha Co., Ltd.

Developing a spinal cord injury rehabilitation service in Madagascar.

Rehabilitation for people with spinal cord injury in many low- and middle-income countries is not avail-able or is in the early stages of development. However, rehabilitation is recognized as crucial in order to optimize functional recovery and outcomes for patients with spinal cord injury. With an increasing incidence of spinal cord injury, the unmet need for rehabilitation is huge. This report describes the early development of a specialist rehabilitation service for spinal cord injury in Madagascar, one of the poorest countries in the world. The sustained input to an expanding rehabilitation team has led to reductions in avoidable complications. The input of the rehabilitation team has been welcomed by the neurosurgery department, which has recognized fewer delays in patients undergoing surgical treatments. Cost, lack of resources and trained staff, and poor understanding of disability continue to provide challenges. However, the development of the rehabilitation service using low technology, but with a high level of knowledge and systematic management, is a source of considerable pride. This development in Madagascar can be regarded as a model for spinal cord injury rehabilitation in other low-resource settings.

Spinal cord injury in patients with ankylosing spondylitis: a 10-year review.

STUDY DESIGN: Retrospective study. OBJECTIVE: To evaluate the clinical and functional outcomes in patients with spinal cord injury (SCI) and preexisting ankylosing spondylitis (AS). SUMMARY OF BACKGROUND DATA: AS alters the strength and biomechanical properties of the spine that renders it susceptible to fracture with minimal trauma. Neurologic involvement is common and outcomes largely depend on the early recognition and appropriate management. METHODS: A 10-year review (1996-2005) was carried out to identify all patients admitted with SCI associated with AS. The cause of injury, prehospital and emergency management, definitive treatment of fracture, final neurology, and functional outcomes were ascertained. Reasons for neurologic deterioration were determined. RESULTS: Eighteen patients were identified. In 15 patients, the injury resulted from trauma (fall 14, road accident 1) and in 3 the SCI followed spinal surgical interventions. Twelve of the 15 patients with traumatic injuries were able to walk immediately after the fall but subsequently deteriorated for various reasons. Spinal epidural hematomas developed in 3 patients (2 traumatic, 1 spinal intervention). The fractures were managed surgically in 3 patients, halo jacket was used in 2, and the remainder were managed expectantly on traction. Four patients died before discharge, 4 were able to walk with an aid at discharge, and the others were wheel chair dependent. CONCLUSION: Neurologic deficits were often subtle on initial presentation, resulting in many injuries being missed because of a low index of suspicion and poor visualization of lower cervical fractures on conventional radiographs. Extension of the ankylosed kyphotic cervical spine during conventional immobilization or for radiologic procedures resulted in neurologic deficits. Patients with an ankylosed cervical spine are normally unable to see the ceiling lying supine because of cervicothoracic kyphosis and use pillows to support their head. Cervical spine alignment in a similar flexed position is essential during immobilization or imaging. Medical alert cards as for patients with diabetes would be a way forward in correctly identifying patients with AS so that appropriate precautions can be instituted by emergency services.