Probiotics for treating acute infectious diarrhoea
Open accessAbstract
BACKGROUND: Probiotics may be effective in reducing the duration of acute infectious diarrhoea. OBJECTIVES: To assess the effects of probiotics in proven or presumed acute infectious diarrhoea. SEARCH METHODS: We searched the trials register of the Cochrane Infectious Diseases Group, MEDLINE, and Embase from inception to 17 December 2019, as well as the Cochrane Controlled Trials Register (Issue 12, 2019), in the Cochrane Library, and reference lists from studies and reviews. We included additional studies identified during external review. SELECTION CRITERIA: Randomized controlled trials comparing a specified probiotic agent with a placebo or no probiotic in people with acute diarrhoea that is proven or presumed to be caused by an infectious agent. DATA COLLECTION AND ANALYSIS: Two review authors independently applied inclusion criteria, assessed risk of bias, and extracted data. Primary outcomes were measures of diarrhoea duration (diarrhoea lasting ≥ 48 hours; duration of diarrhoea). Secondary outcomes were number of people hospitalized in community studies, duration of hospitalization in inpatient studies, diarrhoea lasting ≥ 14 days, and adverse events. MAIN RESULTS: We included 82 studies with a total of 12,127 participants. These studies included 11,526 children (age < 18 years) and 412 adults (three studies recruited 189 adults and children but did not specify numbers in each age group). No cluster-randomized trials were included. Studies varied in the definitions used for "acute diarrhoea" and "end of the diarrhoeal illness" and in the probiotic(s) tested. A total of 53 trials were undertaken in countries where both child and adult mortality was low or very low, and 26 where either child or adult mortality was high. Risk of bias was high or unclear in many studies, and there was marked statistical heterogeneity when findings for the primary outcomes were pooled in meta-analysis. Effect size was similar in the sensitivity analysis and marked heterogeneity persisted. Publication bias was demonstrated from funnel plots for the main outcomes. In our main analysis of the primary outcomes in studies at low risk for all indices of risk of bias, no difference was detected between probiotic and control groups for the risk of diarrhoea lasting ≥ 48 hours (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.91 to 1.09; 2 trials, 1770 participants; moderate-certainty evidence); or for duration of diarrhoea (mean difference (MD) 8.64 hours shorter, 95% CI 29.4 hours shorter to 12.1 hours longer; 6 trials, 3058 participants; very low-certainty evidence). Effect size was similar and marked heterogeneity persisted in pre-specified subgroup analyses of the primary outcomes that included all studies. These included analyses limited to the probiotics Lactobacillus rhamnosus GG and Saccharomyces boulardii. In six trials (433 participants) of Lactobacillus reuteri, there was consistency amongst findings (I² = 0%), but risk of bias was present in all included studies. Heterogeneity also was not explained by types of participants (age, nutritional/socioeconomic status captured by mortality stratum, region of the world where studies were undertaken), diarrhoea in children caused by rotavirus, exposure to antibiotics, and the few studies of children who were also treated with zinc. In addition, there were no clear differences in effect size for the primary outcomes in post hoc analyses according to decade of publication of studies and whether or not trials had been registered. For other outcomes, the duration of hospitalization in inpatient studies on average was shorter in probiotic groups than in control groups but there was marked heterogeneity between studies (I² = 96%; MD -18.03 hours, 95% CI -27.28 to -8.78, random-effects model: 24 trials, 4056 participants). No differences were detected between probiotic and control groups in the number of people with diarrhoea lasting ≥ 14 days (RR 0.49, 95% CI 0.16 to 1.53; 9 studies, 2928 participants) or in risk of hospitalization in community studies (RR 1.26, 95% CI 0.84 to 1.89; 6 studies, 2283 participants). No serious adverse events were attributed to probiotics. AUTHORS' CONCLUSIONS: Probiotics probably make little or no difference to the number of people who have diarrhoea lasting 48 hours or longer, and we are uncertain whether probiotics reduce the duration of diarrhoea. This analysis is based on large trials with low risk of bias.
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In the same Cochrane analysis, the frequency of bowel movements on day 2 of administration was 0.8/day less in the probiotics groups than in the control groups.
“the frequency of bowel movements on day 2 of administration was 0.8/day less in the probiotics groups than in the control groups”
From Guideline for the Antibiotic Use in Acute Gastroenteritis (2019) · cites this paper as [100]
In a Cochrane analysis of 63 studies on 8,014 patients with acute infectious diarrhea, mostly pediatric, the groups receiving probiotics had diarrhea for one day less on average compared to control groups.
“In a Cochrane analysis of 63 studies on 8,014 patients with acute infectious diarrhea, most of whom were pediatric patients, the groups receiving probiotics had diarrhea for one day less on average compared to control groups”
From Guideline for the Antibiotic Use in Acute Gastroenteritis (2019) · cites this paper as [100]
Due to substantive heterogeneity of effect size between studies, evidence was insufficient to show a specific probiotic regimen as more effective than another.
“However, due to substantive heterogeneity of effect size between studies, evidence was insufficient to show a specific probiotic regimen as more effective than another (Allen 2010).”
From Probiotics for treating acute infectious diarrhoea (2020) · cites this paper as Allen 2010
In the previous version of this Cochrane Review, fewer children had diarrhoea lasting four days or longer when probiotics were used.
“Findings from the previous version of this Cochrane Review show that when probiotics were used, the mean duration of diarrhoea was shorter, and fewer children had diarrhoea lasting four days or longer.”
From Probiotics for treating acute infectious diarrhoea (2020) · cites this paper as Allen 2010
In the previous version of this Cochrane Review, when probiotics were used, the mean duration of diarrhoea was shorter.
“Findings from the previous version of this Cochrane Review show that when probiotics were used, the mean duration of diarrhoea was shorter, and fewer children had diarrhoea lasting four days or longer.”
From Probiotics for treating acute infectious diarrhoea (2020) · cites this paper as Allen 2010
Despite the addition of 36 studies since the previous review, there was marked heterogeneity between studies.
“Despite the addition of 36 studies undertaken since our previous review (Allen 2010), there was marked heterogeneity between studies.”
From Probiotics for treating acute infectious diarrhoea (2020) · cites this paper as Allen 2010
Probiotics reduced mean duration of diarrheal symptoms by 24.76 h (95%CI 15.9 - 33.6 h) compared to placebo in acute gastroenteritis.
“This meta-analysis demonstrated a clear, statistically significant reduction in diarrheal symptoms: probiotics reduced the mean duration of diarrheal symptoms by 24.76 h (95%CI 15.9 – 33.6 h) when compared to placebo.”
From Viral Infections, the Microbiome, and Probiotics (2021) · cites this paper as Allen et al., 2010
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- Authors
- Allen, S. J., Martinez, E. G., Gregorio, G. V., & Dans, L. F.
- Affiliations
- Swansea University (GB)
- Philippine General Hospital (PH)
- Venue
- Cochrane Database of Systematic Reviews
- Publisher
- Wiley
- Published
- 2010-11-10
- Volume
- 12
- Issue
- 11
- Pages
- CD003048-CD003048
- ISSN
- 1361-6137 (ISSN-L)
- 1465-1858
- PMC
- PMC6532699
- OpenAlex
- W2110598631
- Cited by
- 628
- References
- 151
- Citations by year
- 2026: 4 · 2025: 25 · 2024: 39 · 2023: 29 · 2022: 51 · 2021: 43 · 2020: 59 · 2019: 52 · 2018: 39 · 2017: 46 · 2016: 29 · 2015: 51 · 2014: 48 · 2013: 39 · 2012: 44
- FWCI
- 4.28
- Type
- journal article
- Language
- en
- Update notices
- new_version (2020-12-08)
- Open access
- bronze
- doi.org
- Locations
- Cochrane Database of Systematic Reviews (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- The Scientific Electronic Library Online (Fundação de Amparo à Pesquisa do Estado de São Paulo) (submittedVersion, other-oa)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Nursing › Nutrition and Dietetics › Infant Nutrition and Health
- Keywords
- probiotics, acute infectious diarrhea, diarrhea duration, children, hospitalization, adverse events, risk of bias, publication bias, heterogeneity, Lactobacillus, Bifidobacterium, Saccharomyces boulardii, Lactococcus lactis, Lactobacillus rhamnosus, Lactobacillus plantarum
- MeSH terms
- Acute Disease, Adult, Child, Child, Preschool, Diarrhea, Humans, Infant, Probiotics
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