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

Johnston, Bradley C.; Lytvyn, Lyubov; Lo, Calvin Ka Fung; Allen, Stephen J.; Wang, Duolao; Szajewska, Hania; Miller, Mark; Ehrhardt, Stephan; Sampalis, John and Duman, Deniz G., et al. (2018) In Infection Control and Hospital Epidemiology p.1-11
Abstract

OBJECTIVE: To determine whether probiotic prophylaxes reduce the odds of Clostridium difficile infection (CDI) in adults and children. DESIGN: Individual participant data (IPD) meta-analysis of randomized controlled trials (RCTs), adjusting for risk factors. METHODS: We 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. RESULTS: Probiotics reduced CDI odds in the unadjusted model (n=6,645; odds ratio [OR] 0.37; 95% confidence... (More)

OBJECTIVE: To determine whether probiotic prophylaxes reduce the odds of Clostridium difficile infection (CDI) in adults and children. DESIGN: Individual participant data (IPD) meta-analysis of randomized controlled trials (RCTs), adjusting for risk factors. METHODS: We 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. RESULTS: Probiotics 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. CONCLUSIONS: Moderate 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 REGISTRATION: PROSPERO 2015 identifier: CRD42015015701 Infect Control Hosp Epidemiol 2018;1–11

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Infection Control and Hospital Epidemiology
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11 pages
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University of Chicago Press
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0899-823X
DOI
10.1017/ice.2018.84
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English
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c4025d6b-1e8d-4e13-8165-17d6ae06ad43
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2018-05-14 13:23:23
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@article{c4025d6b-1e8d-4e13-8165-17d6ae06ad43,
  abstract     = {<p>OBJECTIVE: To determine whether probiotic prophylaxes reduce the odds of Clostridium difficile infection (CDI) in adults and children. DESIGN: Individual participant data (IPD) meta-analysis of randomized controlled trials (RCTs), adjusting for risk factors. METHODS: We 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. RESULTS: Probiotics 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. CONCLUSIONS: Moderate 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 REGISTRATION: PROSPERO 2015 identifier: CRD42015015701 Infect Control Hosp Epidemiol 2018;1–11</p>},
  author       = {Johnston, Bradley C. and Lytvyn, Lyubov and Lo, Calvin Ka Fung and Allen, Stephen J. and Wang, Duolao and Szajewska, Hania and Miller, Mark and Ehrhardt, Stephan and Sampalis, John and Duman, Deniz G. and Pozzoni, Pietro and Colli, Agostino and Lönnermark, Elisabet and Selinger, Christian P. and Wong, Samford and Plummer, Susan and Hickson, Mary and Pancheva, Ruzha and Hirsch, Sandra and Klarin, Bengt and Goldenberg, Joshua Z. and Wang, Li and Mbuagbauw, Lawrence and Foster, Gary and Maw, Anna and Sadeghirad, Behnam and Thabane, Lehana and Mertz, Dominik},
  issn         = {0899-823X},
  language     = {eng},
  month        = {04},
  pages        = {1--11},
  publisher    = {University of Chicago Press},
  series       = {Infection Control and Hospital Epidemiology},
  title        = {Microbial Preparations (Probiotics) for the Prevention of Clostridium difficile Infection in Adults and Children : An Individual Patient Data Meta-analysis of 6,851 Participants},
  url          = {http://dx.doi.org/10.1017/ice.2018.84},
  year         = {2018},
}