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 Lactobacillus casei Shirota probiotic drink reduces antibiotic-associated diarrhoea in patients with spinal cord injuries: a randomised controlled trial.

Certain probiotics may prevent the development of antibiotic-associated diarrhoea (AAD) and Clostridium difficile-associated diarrhoea (CDAD), but their effectiveness depends on both strain and dose. There are few data on nutritional interventions to control AAD/CDAD in the spinal cord injury (SCI) population. The present study aimed to assess (1) the efficacy of consuming a commercially produced probiotic containing at least 6·5 × 109 live Lactobacillus casei Shirota (LcS) in reducing the incidence of AAD/CDAD, and (2) whether undernutrition and proton pump inhibitors (PPI) are risk factors for AAD/CDAD. A total of 164 SCI patients (50·1 (sd 17·8) years) with a requirement for antibiotics (median 21 d, range 5-366) were randomly allocated to receive LcS (n 76) or no probiotic (n 82). LcS was given once daily for the duration of the antibiotic course and continued for 7 days thereafter. Nutritional risk was assessed by the Spinal Nutrition Screening Tool. The LcS group had a significantly lower incidence of AAD (17·1 v. 54·9%, P< 0·001). At baseline, 65% of patients were at undernutrition risk. Undernutrition (64·1 v. 33·3%, P< 0·01) and the use of PPI (38·4 v. 12·1 %, P= 0·022) were found to be associated with AAD. However, no significant difference was observed in nutrient intake between the groups. The multivariate logistic regression analysis identified poor appetite ( < 1/2 meals eaten) (OR 5·04, 95% CI 1·28, 19·84) and no probiotic (OR 8·46, 95% CI 3·22, 22·20) as the independent risk factors for AAD. The present study indicated that LcS could reduce the incidence of AAD in hospitalised SCI patients. A randomised, placebo-controlled study is needed to confirm this apparent therapeutic success in order to translate into improved clinical outcomes.

Nutritional supplement usage in patients admitted to a spinal cord injury center.

OBJECTIVES: To (1) assess food intake; (2) establish the prevalence of dietary supplement usage and its associated cost (oral nutritional supplements (ONS); vitamin and mineral supplements (VMS)) and; (3) identify the characteristics of nutritional supplement users among patients admitted to a spinal cord injury (SCI) center. STUDY DESIGN: A single center survey. METHODS: Standardized questionnaires were used to collect demographic information, food consumption over a 24-hour period, and the use of nutritional supplements. Multivariate logistic regression was used to determine the characteristics of dietary supplement usage and those using them. RESULTS: Seventy-three patients with SCI completed and returned the questionnaires (69.5% response rate). From 67 questionnaires with food intake data, 21 patients (31.3%) consumed three full meals a day. Nine of the full 73 patients (12.3%) received artificial nutritional support, 14 of 73 (19.1%) received ONS, 34 of 73 (46.5%) received VMS, and 31 of 73 (42.4%) required assistance in order to eat. The three supplements most often prescribed were multivitamins (19.1%), vitamins B (17.8%), and vitamin D (13.6%). VMS use was associated with age (years: >60 vs. ≤ 60: 62.1 vs. 34.1%, P = 0.019), nutrition risk (Spinal Nutrition Screening Tool (≥ 11 vs. <11: 65.7 vs. 28.9%, P = 0.001), and serum albumin concentration (<35 vs. ≥ 35 g/l: 59.6 vs. 16%, P < 0.01). Patients at nutrition risk were found to consume more ONS than the lower risk group (28.5 vs. 10.5%, P = 0.05). The expenditures on ONS and VMS were higher in the group at greater nutritional risk (£1878.3 vs. £914.3, P = 0.005). CONCLUSION: The use of nutritional supplements is common in patients with SCI, particularly in older adults and patients with poor nutritional state. However, the present study identified only small numbers of patients consuming all of their hospital meals, which may well contribute to undernutrition risk. Given that a high proportion of patients with SCI require assistance to eat, we suggest that further efforts focus on the feasibility of providing feeding assistants, and on reviewing the nature of the hospital menu.

Prevalence of vitamin D deficiency in patients with spinal cord injury at admission: a single-centred study in the UK.

Vitamin D deficiency is prevalent in patients with chronic spinal cord injury (SCI) and has been implicated as an aetiologic factor of osteoporosis and various skeletal and extra-skeletal issues in SCI patients. Few data were available regarding vitamin D status in patients with acute SCI or immediately assessed at hospital admission. This retrospective cross-sectional study evaluated vitamin D status in SCI patients at admission to a UK SCI centre in January-December 2017. A total of 196 eligible patients with serum 25(OH)D concentration records at admission were recruited. The results found that 24 % were vitamin D deficient (serum 25(OH)D < 25 nmol/l), 57 % of the patients had serum 25(OH)D < 50 nmol/l. The male patients, patients admitted in the winter-spring time (December-May), and patients with serum sodium < 135 mmol/l or with non-traumatic causes had a significant higher prevalence of vitamin D deficiency than their counterparts (28 % males v. 11⋅8 % females, P = 0⋅02; 30⋅2 % in winter-spring v. 12⋅9 % in summer-autumn, P = 0⋅007; 32⋅1 % non-traumatic v. 17⋅6 % traumatic SCI, P = 0⋅03; 38⋅9 % low serum sodium v. 18⋅8 % normal serum sodium, P = 0⋅010). There was a significant inverse association of serum 25(OH)D concentration with body mass index (BMI) (r = -0⋅311, P = 0⋅002), serum total cholesterol (r = -0⋅168, P = 0⋅04) and creatinine concentrations (r = -0⋅162, P = 0⋅02) that were also significant predictors of serum 25(OH)D concentration. Strategies for systematic screening and efficacy of vitamin D supplementation in SCI patients need to be implemented and further investigated to prevent the vitamin D deficiency-related chronic complications.

The prevalence of malnutrition in spinal cord injuries patients: a UK multicentre study.

Data on the prevalence of malnutrition among patients with spinal cord injuries (SCI) are lacking. The aim of the present study was to assess nutritional risk at admission, and the status of nutritional support in the UK SCI Centres (SCIC); a cross-sectional, multicentre study in four SCIC. A standardised questionnaire was used and distributed to the participating SCIC. After obtaining informed consent, baseline demographic data, nutritional risk score by the 'Malnutrition Universal Screening Tool', BMI and routine blood biochemistry were collected from every patient admitted to an SCIC. The four SCIC, comprising 48·2 % of the total UK SCI beds, contributed data from 150 patients. On admission, 44·3 % of patients were malnourished or at risk of undernutrition. Nutritional risk was more common in patients with acute high cervical SCI than those with lower SCI (60·7 v. 34·5 %), and nutritional risk was more common in those with additional complications including ventilatory support (with tracheostomy, 56·3 v. 38·7 %). Also, 45 % of patients were at risk of overnutrition (BMI ≥ 25 kg/m2). The prevalence of malnutrition in SCI patients admitted to SCIC is higher than national figures focused on general hospitalised patients, indicating that SCI patients are particularly vulnerable to malnutrition. Patients with SCI who have a tracheostomy may need additional attention. Given the potential negative impact of malnutrition on clinical outcomes, an emphasis on mandatory nutrition screening, followed by detailed assessment for at-risk individuals should be in place in the SCIC.

Predictive equations over estimating resting metabolic rate in individual with spinal cord injury requiring mechanical ventilation support - A case series.

Context: The impact of mechanical ventilation on energy expenditure after spinal cord injury (SCI) is sparse. The objective of this case-series is to measure 15-minutes resting metabolic rate (RMR) to determine 24-hours measured-RMR (m-RMR) using QUARK indirect calorimeter (IC) and; compare the m-RMR with estimated RMR (e-RMR) using four commonly used predictive equations (Harris-Benedict, Mifflin St-Jeor, Henry and Schofield).Findings: We measured the RMR of four patients with SCI (one male and three female; mean age: 58.3 years) all with complete tetraplegia (ISNCSCI A) twice in a one-week interval using an IC with two sampling flow settings during a six month period. The median (IQ) of all m-RMRs was 1094 (340.2) kcal/day. The median m-RMR was 40.1% lower than the median calculated with four different e-RMRs using predictive equations. All four predictive equations overestimated RMR in SCI patients requiring mechanical ventilation by 4.1-61.1% (Harris-Benedict: 28.8-60.6%; Mifflin St-Jeor: 6.9-61.1%; Henry: 4.1-58.9% and; Schofield: 6-54.6%).Conclusion/clinical relevance: There is a high variability of e-RMR and m-RMR in patients with SCI who are dependent on mechanical ventilation. The use of predictive equations may lead to over-estimation of energy requirements. To avoid overfeeding we recommended measuring RMR using IC wherever possible. A further study with a larger sample size is needed due to the small number of subjects in our case-series. Development of a validated RMR equation in the SCI population is warranted.

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.

Detecting malnutrition risk and obesity after spinal cord injury: a quality improvement project and systematic review.

BACKGROUND/OBJECTIVES: Malnutrition and overweight are a major concern after spinal cord injury (SCI). There is limited information available for prevalence of malnutrition, overweight and nutrition screening compliance. The aim of this study is to (1) determine whether the quality improvement initiative is successful in improving nutrition screening and to (2) systematic review the literature on prevalence of malnutrition and overweight after SCI. SUBJECTS/METHODS: The quality improvement project was conducted during November 2013 to October 2017. Nutrition screening data (presence of a correctly completed Spinal Nutrition Screening Tool (SNST) within 24 h of admission) were collected weekly. Literatures on disease-related malnutrition prevalence in adult SCI patients published from inception to 17 March 2017 were included in the systematic review. RESULTS: Two thousand four hundred and sixty-two SCI (49.3% tetraplegia; 47.6% complete SCI) patients (mean age: 76.7 ± 16.2 years, 70.6% men) were included. Nutrition screening compliance increased significantly overtime (2013-2014: 49.3%; 2014-2015: 69.7%; 2015-2016: 80.7%; 2016-207: 76.7%, p < 0.01). Eighty-four articles were identified from the systematic review, of these nine studies with 9265 SCI patients were included. There was considerable variability in methodology and prevalence of malnutrition risk (three nutrition screening tools were reported: body mass index (BMI); Malnutrition Universal Screening Tool; SNST). The prevalence of undernutrition was in the range of 40-50%. Three different BMI cutoffs were reported as overweight's cut-off (>22, >23 and >25 kg/m2). The prevalence of overweight was in the range of 45-69.2%. CONCLUSIONS: Malnutrition and overweight is a highly prevalent condition after SCI. Further research is warranted to characterise screening practices and identify evidence-based interventions to this ongoing and costly clinical and public health issue.

Microbial Preparations (Probiotics) for the Prevention of Clostridium difficile Infection in Adults and Children: An Individual Patient Data Meta-analysis of 6,851 Participants.

OBJECTIVETo determine whether probiotic prophylaxes reduce the odds of Clostridium difficile infection (CDI) in adults and children.DESIGNIndividual participant data (IPD) meta-analysis of randomized controlled trials (RCTs), adjusting for risk factors.METHODSWe searched 6 databases and 11 grey literature sources from inception to April 2016. We identified 32 RCTs (n=8,713); among them, 18 RCTs provided IPD (n=6,851 participants) comparing probiotic prophylaxis to placebo or no treatment (standard care). One reviewer prepared the IPD, and 2 reviewers extracted data, rated study quality, and graded evidence quality.RESULTSProbiotics reduced CDI odds in the unadjusted model (n=6,645; odds ratio [OR] 0.37; 95% confidence interval [CI], 0.25-0.55) and the adjusted model (n=5,074; OR, 0.35; 95% CI, 0.23-0.55). Using 2 or more antibiotics increased the odds of CDI (OR, 2.20; 95% CI, 1.11-4.37), whereas age, sex, hospitalization status, and high-risk antibiotic exposure did not. Adjusted subgroup analyses suggested that, compared to no probiotics, multispecies probiotics were more beneficial than single-species probiotics, as was using probiotics in clinical settings where the CDI risk is ≥5%. Of 18 studies, 14 reported adverse events. In 11 of these 14 studies, the adverse events were retained in the adjusted model. Odds for serious adverse events were similar for both groups in the unadjusted analyses (n=4,990; OR, 1.06; 95% CI, 0.89-1.26) and adjusted analyses (n=4,718; OR, 1.06; 95% CI, 0.89-1.28). Missing outcome data for CDI ranged from 0% to 25.8%. Our analyses were robust to a sensitivity analysis for missingness.CONCLUSIONSModerate quality (ie, certainty) evidence suggests that probiotic prophylaxis may be a useful and safe CDI prevention strategy, particularly among participants taking 2 or more antibiotics and in hospital settings where the risk of CDI is ≥5%.TRIAL REGISTRATIONPROSPERO 2015 identifier: CRD42015015701Infect Control Hosp Epidemiol 2018;771-781.

Effectiveness of probiotic in preventing and treating antibiotic-associated diarrhoea and/or Clostridium difficile-associated diarrhoea in patients with spinal cord injury: a protocol of systematic review of randomised controlled trials.

BACKGROUND: Probiotics may prevent antibiotic-associated and Clostridium difficile-associated diarrhoea (AAD/CDAD). Many spinal cord injury centre (SCIC) practitioners consider probiotics generically and may not realise that efficacy can be strain-, dose- and disease-specific. In order to confirm these effects and fully evaluate the extent of probiotic effectiveness in these patients, a systematic review and meta-analysis is indicated. METHODS: The following databases will be searched for relevant studies: Cochrane Library; Centre for Reviews and Dissemination (CRD) Database; CINAHL; PsycINFO; Embase; Medline; AMED; International Clinical Trials Registry Platform Search Portal and ISRCTN Registry and will hand search a list of conference proceedings. Any randomised controlled trials without restriction of publication status will be included with treatment of AAD/CDAD. Outcomes will include the effect of probiotic on the occurrence of AAD/CDAD and duration of diarrhoea, intensive care unit admission, hospital mortality and length of hospital stay. Two reviewers will independently screen the titles, abstracts or even full texts and extract data. Two other reviewers will assess study quality. Revman 5.1 software will be used to conduct meta-analysis and calculate the risk ratio for dichotomous data. Weighted mean difference or standard mean difference will be calculated for continuous data. The Cochrane Collaboration's tool will be used to assess the risk of bias. DISCUSSION: This systematic review protocol will provide information on probiotic therapy for AAD and CDAD in spinal cord injury (SCI) population. The results will be disseminated through peer-reviewed publication or conference presentation. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015016976.