The quality of evidence is downgraded by study limitations (unclear allocation concealment and lack of blinding).
A Cochrane review [Abstract] 1 included 33 studies with a total of 6 352 children aged from 3 days to 18 years (6 studies in those ≤2 years, 26 studies in those ≥2 years) receiving antibiotics. The studies assessed the efficacy and safety of probiotics used for the prevention of antibiotic-associated diarrhea (AAD). The studies were short-term, ranging in length from 5 days to 12 weeks. 19 different probiotic interventions were used including different species and/or strains as well as dosages versus placebo (19 studies), no probiotics (12 studies) and active control (2 studies). Probiotics assessed included Bacillus spp., Bifidobacterium spp., Clostridium butyricum, Lactobacilli spp., Lactococcus spp., Leuconostoc cremoris, Saccharomyces spp., or Streptococcus spp., alone or in combination.
Probiotics reduced the incidence of antibiotic-associated diarrhea (table T1). A subgroup analysis exploring heterogeneity indicated that high dose (≥ 5 billion CFUs per day) was more effective than low probiotic dose (< 5 billion CFUs per day; interaction P value = 0.01). For the low dose studies the incidence of AAD in the probiotic group was not statistically significant (RR 0.68; 95% CI 0.46 to 1.01). Duration of diarrhea was reduced by almost one day (MD -0.91 days, 95% CI -1.38 to -0.44 days, statistical heterogeneity I2 =84%; 8 studies, n=1 263).
| Outcome | Follow-up | Relative effect (95% CI) | Risk in control | Risk with probiotics | Participants (studies) | NNTB (95% CI) |
|---|---|---|---|---|---|---|
| Incidence of AAD | 5 days to 12 weeks | RR 0.45 (0.36 to 0.56)* | 190 per 1000 | 86 per 1000(68 to 106) | 6 352(33 studies) | 9 (7 to 13) |
| Incidence of AAD: Probiotic dose (≥5 billion CFUs of probiotics/day) | 5 days to 12 weeks | RR 0.37 (0.30 to 0.46) | 190 per 1000 | 70 per 1000(57 to 87) | 4 038(20 studies) | 6 (CI 5 to 9) |
| Adverse events | 5 days to 4 weeks | RD -0.00 (-0.01 to 0.01)** | 55 per 1000 | 39 per 1000(25 to 61) | 4 415(24 studies) |
| AAD = antibiotic-associated diarrhea; NNTB = number needed to treat for an additional beneficial outcome Statistical heterogeneity: *I2 =57%, **I2 =75% | ||||||
| Six studies administered Lactobacillus rhamnosus species and 9 studied the yeast Saccharomyces boulardii. Lactobacillus rhamnosus (RR 0.37, 95% CI 0.24 to 0.55; 6 studies, n=686) and Saccharomyces boulardii (RR 0.36, 95% CI 0.24 to 0.54; I² = 76%; 9 studies, n=3165) decreased the incidence of diarrhea compared to control.
None of the 24 studies that reported on adverse events reported any serious adverse events attributable to probiotics. Adverse event rates were low. Common adverse events included rash, nausea, gas, flatulence, abdominal bloating, and constipation. Clinical commentsNoteAlthough no serious adverse events were observed among mostly healthy children, serious adverse events have been reported in observational studies not included in this review, including severely debilitated or immuno-compromised children with underlying risk factors including central venous catheter use and disorders associated with bacterial/fungal translocation (the passage of bacteria from the gut to other areas of the body). Date of latest search: References
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