PMID 22570464 Probiotics for the prevention and treatment of antibiotic-associated diarrhea: a systematic review and meta-analysis Meta-analysis · JAMA, 2012 63 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s, 11,811 people - probiotics lowered antibiotic-associated diarrhea by 42% (RR 0.58), but strains were poorly documented.
Key summary
A systematic review and meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. searching 12 databases and including 82 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s. Pooling the 63 RCTs (11,811 participants) that reported the outcome, probiotics significantly lowered the risk of antibiotic-associated diarrhea (AAD) (relative risk 0.58, 95% CI 0.50–0.68, one case prevented per 13 treated). Most used Lactobacillus-based products, but strains were poorly documented and heterogeneity was high, so the review could not conclude which strain is most effective for which patients or antibiotics.
Show original abstract
CONTEXT: Probiotics are live microorganisms intended to confer a health benefit when consumed. One condition for which probiotics have been advocated is the diarrhea that is a common adverse effect of antibiotic use. OBJECTIVE: To evaluate the evidence for probiotic use in the prevention and treatment of antibiotic-associated diarrhea (AAD). RESULTS: A total of 82 RCTs met inclusion criteria. The majority used Lactobacillus-based interventions alone or in combination with other genera; strains were poorly documented. The pooled relative risk in a DerSimonian-Laird random-effects meta-analysis of 63 RCTs, which included 11 811 participants, indicated a statistically significant association of probiotic administration with reduction in AAD (relative risk, 0.58; 95% CI, 0.50 to 0.68; P < .001; I(2), 54%; [risk difference, -0.07; 95% CI, -0.10 to -0.05], [number needed to treat, 13; 95% CI, 10.3 to 19.1]) in trials reporting on the number of patients with AAD. However, there exists significant heterogeneity in pooled results and the evidence is insufficient to determine whether this association varies systematically by population, antibiotic characteristic, or probiotic preparation. CONCLUSIONS: The pooled evidence suggests that probiotics are associated with a reduction in AAD. More research is needed to determine which probiotics are associated with the greatest efficacy and for which patients receiving which specific antibiotics. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 29257353 Probiotics for the prevention of Clostridium difficile-associated diarrhea in adults and children Meta-analysis (Cochrane) · Cochrane Database Syst Rev, 2017 31 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s, 8,672 people - probiotics lowered C. difficile diarrhea by 60% (RR 0.40), with benefit concentrated in high-risk patients.
Key summary
A CochraneAn international network that rigorously reviews and synthesizes evidence. review of 39 studies. Pooling the 31 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s (8,672 participants) on C. difficile-associated diarrhea (CDAD), probiotics lowered its incidence by 60% (1.5% vs 4.0%, relative risk 0.40, GRADEAn international standard for rating the certainty of evidence from high to very low. moderate). In a post hoc analysis, however, the benefit was concentrated in patients whose baseline risk exceeded 5% (a 70% reduction), with no difference in those at or below 5% risk. The authors judged that short-term use alongside antibiotics is generally safe and effective in patients who are not immunocompromised or severely debilitated.
Show original abstract
BACKGROUND: Antibiotics can disturb gastrointestinal microbiota which may lead to reduced resistance to pathogens such as Clostridium difficile (C. difficile). Probiotics are live microbial preparations that, when administered in adequate amounts, may confer a health benefit to the host, and are a potential C. difficile prevention strategy. OBJECTIVES: To assess the efficacy and safety of probiotics for preventing C.difficile-associated diarrhea (CDAD) in adults and children. MAIN RESULTS: Thirty-nine studies (9955 participants) met the eligibility requirements for our review. A complete case analysis among trials investigating CDAD (31 trials, 8672 participants) suggests that probiotics reduce the risk of CDAD by 60%. The incidence of CDAD was 1.5% (70/4525) in the probiotic group compared to 4.0% (164/4147) in the placebo or no treatment control group (RR 0.40, 95% CI 0.30 to 0.52; GRADE = moderate). However, in a post hoc analysis, we did observe a subgroup effect with respect to baseline risk of developing CDAD. Trials with a baseline CDAD risk of 0% to 2% and 3% to 5% did not show any difference in risk but trials enrolling participants with a baseline risk of > 5% for developing CDAD demonstrated a large 70% risk reduction (interaction P value = 0.01). AUTHORS' CONCLUSIONS: Based on this systematic review and meta-analysis of 31 randomized controlled trials including 8672 patients, moderate certainty evidence suggests that probiotics are effective for preventing CDAD (NNTB = 42 patients, 95% CI 32 to 58). Our post hoc subgroup analyses to explore heterogeneity indicated that probiotics are effective among trials with a CDAD baseline risk >5% (NNTB = 12; moderate certainty evidence), but not among trials with a baseline risk ≤5% (low to moderate certainty evidence). The short-term use of probiotics appears to be safe and effective when used along with antibiotics in patients who are not immunocompromised or severely debilitated. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 30462938 Lactobacillus rhamnosus GG versus Placebo for Acute Gastroenteritis in Children RCT · N Engl J Med, 2018 971 children - Lactobacillus rhamnosus GG did not reduce acute gastroenteritis symptoms, diarrhea, or vomiting versus placeboAn inert dummy treatment used as the comparison baseline. (RR 0.96).
Key summary
A large randomized, double-blind trial in 971 children with acute gastroenteritis at 10 U.S. pediatric emergency departments. Lactobacillus rhamnosus GG (1×10^10 CFU twice daily for 5 days) did not reduce moderate-to-severe gastroenteritis within 14 days versus placeboAn inert dummy treatment used as the comparison baseline. (relative risk 0.96, 95% CI 0.68–1.35), and there was no difference in duration of diarrhea (median 49.7 vs 50.9 hours), vomiting, or day-care absenteeism. The finding is that probiotics do not help acute gastroenteritis in children.
Show original abstract
BACKGROUND: Acute gastroenteritis develops in millions of children in the United States every year, and treatment with probiotics is common. However, data to support the use of probiotics in this population are limited. METHODS: We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG at a dose of 1×1010 colony-forming units twice daily or matching placebo. The primary outcome was moderate-to-severe gastroenteritis, which was defined as an illness episode with a total score on the modified Vesikari scale of 9 or higher, within 14 days after enrollment. RESULTS: Among the 971 participants, 943 (97.1%) completed the trial. The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group (relative risk, 0.96; 95% confidence interval, 0.68 to 1.35; P=0.83). There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting, or day-care absenteeism. CONCLUSIONS: Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 30462939 Multicenter Trial of a Combination Probiotic for Children with Gastroenteritis RCT · N Engl J Med, 2018 886 children (PROGUT) - a combination probiotic (L. rhamnosus·L. helveticus) did not improve gastroenteritis outcomes versus placeboAn inert dummy treatment used as the comparison baseline. (OR 1.06).
Key summary
A randomized, double-blind trial (PROGUT) in 886 children with gastroenteritis at six Canadian pediatric emergency departments. A combination product (L. rhamnosus R0011 + L. helveticus R0052, 4×10^9 CFU twice daily for 5 days) did not prevent moderate-to-severe gastroenteritis within 14 days versus placeboAn inert dummy treatment used as the comparison baseline. (odds ratio 1.06, 95% CI 0.77–1.46), with no difference in the duration of diarrhea or vomiting. This is a null result in the same direction as the U.S. trial above.
Show original abstract
BACKGROUND: Gastroenteritis accounts for approximately 1.7 million visits to the emergency department (ED) by children in the United States every year. Data to determine whether the use of probiotics improves outcomes in these children are lacking. METHODS: We conducted a randomized, double-blind trial involving 886 children 3 to 48 months of age with gastroenteritis who presented to six pediatric EDs in Canada. Participants received a 5-day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and L. helveticus R0052, at a dose of 4.0×109 colony-forming units twice daily or placebo. The primary outcome was moderate-to-severe gastroenteritis, which was defined according to a post-enrollment modified Vesikari scale symptom score of 9 or higher. RESULTS: Moderate-to-severe gastroenteritis within 14 days after enrollment occurred in 108 of 414 participants (26.1%) who were assigned to probiotics and 102 of 413 participants (24.7%) who were assigned to placebo (odds ratio, 1.06; 95% confidence interval [CI], 0.77 to 1.46; P=0.72). There were no significant differences between the probiotic group and the placebo group in the median duration of diarrhea or vomiting. CONCLUSIONS: In children who presented to the emergency department with gastroenteritis, twice-daily administration of a combined L. rhamnosus-L. helveticus probiotic did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrollment. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ PMID 25927096 Probiotics for preventing acute upper respiratory tract infections Meta-analysis (Cochrane) · Cochrane Database Syst Rev, 2015 12 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s, 3,720 people - probiotics reduced cold episodes, duration, and antibiotic use, but the evidence quality was low to very low.
Key summary
A CochraneAn international network that rigorously reviews and synthesizes evidence. meta-analysisA statistical synthesis combining results of multiple studies into one conclusion. of 12 RCTRandomized controlled trial - a high-reliability trial that randomly assigns participants to compare effects.s and 3,720 participants (children, adults, and older people). Probiotics reduced the number of people who had at least one episode of acute upper respiratory infection (odds ratio 0.53), shortened an episode by about 1.9 days, and lowered antibiotic prescription rates versus placeboAn inert dummy treatment used as the comparison baseline.. For most outcomes, however, the quality of evidence was rated low or very low, so a benefit is possible but not certain.
Show original abstract
BACKGROUND: Probiotics may improve a person's health by regulating their immune function. Some trials have shown that probiotic strains can prevent respiratory infections. OBJECTIVES: To assess the effectiveness and safety of probiotics (any specified strain or dose), compared with placebo, in the prevention of acute URTIs in people of all ages, at risk of acute URTIs. MAIN RESULTS: We included 13 RCTs, although we could only extract data to meta-analyse 12 trials, which involved 3720 participants including children, adults (aged around 40 years) and older people. We found that probiotics were better than placebo when measuring the number of participants experiencing episodes of acute URTI (at least one episode: odds ratio (OR) 0.53; 95% confidence interval (CI) 0.37 to 0.76, P value < 0.001, low quality evidence); the mean duration of an episode of acute URTI (mean difference (MD) -1.89; 95% CI -2.03 to -1.75, P value < 0.001, low quality evidence); reduced antibiotic prescription rates for acute URTIs (OR 0.65; 95% CI 0.45 to 0.94, moderate quality evidence). AUTHORS' CONCLUSIONS: Probiotics were better than placebo in reducing the number of participants experiencing episodes of acute URTI, the mean duration of an episode of acute URTI, antibiotic use and cold-related school absence. This indicates that probiotics may be more beneficial than placebo for preventing acute URTIs. However, the quality of the evidence was low or very low. ※ The abstract text as collected and stored via the API by the pipeline. The key summary is written based solely on this text.
View original ↗ 