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S. boulardii probiotic does not reduce antibiotic, C. difficile diarrhea
Administration of a Saccharomyces boulardii probiotic treatment to hospital patients receiving antibiotics appeared to have no impact on the incidence of antibiotic- and Clostridium difficile-associated diarrhea, according to the results of a recent trial.
The randomized, placebo-controlled trial was stopped early for futility, and joins other weak or mixed evidence on the use of S. boulardii to reduce antibiotic-associated diarrhea (AAD), the researchers wrote.
“Several strategies have been put forward to prevent AAD and [C. difficile-associated diarrhea (CDAD)] in health care settings, among which the co-administration of yeast or microbial preparations (probiotics) is thought to be promising,” they wrote. “We found no statistical difference between the risk of AAD in the S. boulardii and the placebo group.”
No differences in severity, duration
From July 2010 to October 2012, the researchers randomly assigned 477 patients at 15 German hospitals to receive either oral S. boulardii capsules or placebo twice daily. Patients were eligible if they received systemic antibiotic treatment of one or more antibiotics. The intervention was initiated immediately after receipt of an antibiotic, and was continued for 1 week after treatment was discontinued. Following this, researchers monitored patients for up to 6 weeks, with all data collected through a combination of participant diaries and weekly telephone interviews. The study’s primary research outcome was the risk for AAD, with secondary outcomes including risk for CDAD, average duration and density of AAD or CDAD, and risk for discontinuation or change of administered antibiotics.
Baseline characteristics were similar among patients in both study groups. Sixty-one percent provided complete observations of their daily stools and were included in a per-protocol analysis, while all 477 participants were included in an intention-to-treat analysis.
Compared with placebo, patients who received S. boulardii reported a similar number of AAD episodes during the study period (HR = 1.02; 95% CI, 0.55-1.9). There were no variables within these groups associated with increased AAD risk.
The researchers saw no significant differences in the risk for AAD without signs of CDAD, the incidence of CDAD, duration of AAD, the time to onset of AAD or changes to a secondary antibiotic between the two groups. There were nine serious adverse events reported among the intervention group and three in the placebo group, but none was related to study participation.
Although the initial study design anticipated a larger pool of eligible participants, the observed data suggest that increasing the sample size would have no difference in incidence among the two groups, the researchers wrote. As such, the trial and further analyses were halted for futility.
“We found no evidence for the efficacy of the tested S. boulardii regimen to prevent AAD in a population of hospitalized patients who received systemic antibiotic treatment,” the researchers concluded.
L. rhamnosus GG treatment appears effective against AAD
While the efficacy of S. boulardii remains in question, other data have shown that probiotic treatments with another bacterium, Lactobacillus rhamnosus GG (LGG, Dicofarm), could have an impact on AAD in children and adults.
In a recent systematic review and meta-analysis, researchers from the department of pediatrics at the Medical University of Warsaw in Poland examined data from 12 randomized controlled trials published up to July 2015 evaluating LGG for the prevention of AAD in children and adults treated with antibiotics for any reason (n = 1,499). The daily dose of LGG ranged from 4 x 108 to 12 x 1010 colony forming units, types of antibiotics received varied widely and follow-up ranged from 10 days to 3 months.
Data from 11 of the included RCTs (n = 1,308) showed LGG reduced the risk for AAD from 22.4% to 12.3% compared with placebo or no additional treatment (RR = 0.49; 95% CI, 0.29-0.83), although this evidence was considered to be of low quality. Moderate quality data from five of the included RCTs evaluating children (n = 445) showed the reduced risk for antibiotic-associated diarrhea (23% to 9.6%) was only significant in pediatric patients (RR = 0.48; 95% CI, 0.26-0.89), while other low-quality evidence from four RCTs (n = 280) showed the reduced risk among adults was only significant in those who received antibiotics as part of Helicobacter pylori eradication therapy (RR = 0.26; 95% CI, 0.11-0.59). In addition, data from eight of the RCTs showed LGG to be well-tolerated among patients.
“Current evidence justified the use of LGG for preventing AAD, although a number of questions remain unanswered and the [quality of evidence] calls for caution,” the researchers wrote. – by Dave Muoio
Disclosure: Szajewska reports she has served as a speaker for Dicofarm, the manufacturer of LGG.