A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Saccharomyces boulardii in Infants and Children With Acute Diarrhea

Mourey, Florian; Sureja, Varun P; Kheni, Dharmeshkumar; Shah, Parthiv; Parikh, Devang; Upadhyay, Unmesh; Satia, Milan C.; Shah, Dhara; Troise, Charlotte; Decherf, Amélie Cayzeele

doi:10.1097/inf.0000000000002849

Cited by 18 publications

(11 citation statements)

References 22 publications

(22 reference statements)

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“…Previous studies of probiotics in the treatment of diarrhea have mostly focused on acute diarrhea, viral diarrhea or AAD, and many have confirmed the effectiveness of probiotics for diarrhea symptoms in these cases (17)(18)(19)(20).…”

Section: Discussionmentioning

confidence: 98%

Comparison of safety, effectiveness and serum inflammatory factor indexes of Saccharomyces boulardii versus Bifidobacterium triple viable in treating children with chronic diarrhea: a randomized trial

Zhang¹,

Wan²,

Gui³

2021

Transl Pediatr

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Background: Diarrhea is common in children under 5 years of age and is an important public health problem in China. CD is the main obstacle to the growth and development of children, which brings a great burden to individuals, families and society. The objective of this work is to study the efficacy and safety of Saccharomyces boulardii versus Bifidobacterium triple viable in the treatment of CD in children.Methods: From October 2018 to October 2020, a total of 161 children aged 2-8 years hospitalized with CD were randomly allocated into S. boulardii group, Bifidobacterium triple viable group and control group. After 14 days of treatment, the curative effect and recovery time of the three groups were evaluated. The levels of serum interleukin (IL)-6, IL-7 and tumor necrosis factor-alpha (TNF-α) before and after the treatment were valuated and compared among the three groups, together with clinical efficacy and safety. Results:The recovery time of the Bifidobacterium triple viable group was significantly shorter than that of S. boulardii group (P<0.05). The marked effective rate and total effective rate of the Bifidobacterium triple viable group were significantly higher than those of the control group (P<0.05); the total effective rate of the S. boulardii group was significantly higher than that of the control group (P<0.05). The improvement in the levels of IL-6, IL-7 and TNF-α in the Bifidobacterium triple viable group was greater than that in the control group; the improvement in IL-6 and IL-7 levels in the Bifidobacterium triple viable group was greater than that in the S. boulardii group; the improvement in IL-6 and IL-7 levels in the S. boulardii group was greater than that in the control group, and the differences were statistically significant (P<0.05) Conclusions:The efficacy of Bifidobacterium triple viable and S. boulardii in the treatment of children with CD was better than that of conventional treatment. The treatment effect for Bifidobacterium triple viable was more significant, and it was proved to be safe, to shorten the course of disease, and have clinical relevance.

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Section: Discussionmentioning

confidence: 98%

Comparison of safety, effectiveness and serum inflammatory factor indexes of Saccharomyces boulardii versus Bifidobacterium triple viable in treating children with chronic diarrhea: a randomized trial

Zhang¹,

Wan²,

Gui³

2021

Transl Pediatr

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“…Furthermore, Huang et al (18) have shown that bacterial probiotic therapy shortens the duration of acute diarrheal illness in children. Mourey et al (19) have shown that probiotics in children with acute diarrhea were shown effective in decreasing the severity and duration of diarrhea in children.…”

Section: Discussionmentioning

confidence: 99%

Saccharomyces boulardii plus azithromycin is superior to azithromycin alone in reducing the duration of diarrhea in children with acute colitis: a double-blind randomized placebo-controlled trial

et al. 2022

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Introduction: Diarrheal disorders remain a major disease burden throughout the world in pediatrics that remains a health problem. Several treatment methods have been proposed to treat diarrhea, however each of them has some problems. Objectives: The aim of this study was the evaluation the effect of oral Saccharomyces boulardii on the duration and severity of colitis. Patients and Methods: This randomized clinical trial study included ninety-four patients with acute colitis were enrolled. The children were divided randomly into case and control groups. The control group received supportive treatment including intravenous or oral fluid therapy (ORS solution), antibiotic treatment with azithromycin suspension, and zinc sulfate syrup daily for five days. In addition to the mentioned treatments, the intervention group received S. boulardii as a probiotic capsule. Then, the duration and severity of diarrhea based on the Vesikari score were evaluated for all the patients for five first days. Results: The mean of Vesikari score after the first day in both groups was similar, while after the third and fifth day in the probiotic group this score was lower than the control group (5.11 ± 1.73 versus 6.13 ± 2.25, P=0.031 and 2.36 ± 1.16 versus 4.28 ±1.19, P<0.001, respectively). Furthermore, the number of diarrhea per day in the probiotic group was significantly lower after the first day in contrast to the control group, which remains significant at the end of the fifth day (2.32 ± 0.51 versus 2.83 ± 1.23, P=0.047). Moreover, we found that the diarrhea duration (P<0.001), fever duration (P=0.029), and duration of hospitalization (P=0.006) were statistically lower in the case group as compared to the control. Conclusion: Saccharomyces boulardii had a beneficial effect as a probiotic agent in reducing the severity and duration of diarrhea, which could be beneficial for the treatment of colitis. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20161026030525N2); https://www.irct.ir/trial/24229; ethical code: IR.AJUMS.REC.1395.54.

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“…Twelve articles (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19) with 744 patients were included in the current meta-analysis and were published between 2010 and 2020. Three studies (12,15,17) used combined probiotics for the treatment method, with 2-5 collective probiotic species.…”

Section: Basic Characteristics Of the Included Rctsmentioning

confidence: 99%

“…Six articles (8,9,11,13,18,19) reported changes in diarrhea in children 2 days after the treatment intervention, and the 2-day treatment efficacy rate for diarrhea in the probiotics group was greater than in the control group (OR =2.12, 95% CI: 1.47-3.05, Z=3.998, P=0.000). Statistical heterogeneity was evident between the articles (I 2 =46.6%, P=0.096) (Figure 3).…”

Section: The 2-day Treatment Efficacy Rate For Diarrhea (%)mentioning

confidence: 99%

Efficacy of probiotics in the treatment of acute diarrhea in children: a systematic review and meta-analysis of clinical trials

Huang¹,

Xing²,

Liu³

et al. 2021

Transl Pediatr

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Background: If acute diarrhea in children is not treated promptly and effectively, it can lead to severe dehydration and serious sequelae. Due to the imbalance of intestinal bacteria in children with acute diarrhea, the supplementation with probiotics is important, which can improve the intestinal microenvironment, promote immunity, and enhance resistance. This meta-analysis provides further evidence and discussion of the therapeutic effect of probiotics on acute diarrhea in children.Methods: MEDLINE, EMBASE, PubMed, and the Cochrane Library databases were searched by rapid matching. The input keywords were as follows: (probiotics/synbiotics) and (child/children) and (acute diarrhea/acute gastroenteritis). Articles reporting on randomized controlled trials (RCTs) of probiotics in treating acute diarrhea in children were retrieved. The studies were published from 2010 to 2020. After screening and quality evaluation, Stata 16.0 software was used for the analysis.Results: Twelve articles with 744 patients were included in the study, and the overall quality of the articles was excellent. Meta-analysis showed that the duration of diarrhea in the probiotics group was shorter than that in the control group [standard mean difference (SMD) =−0.74, 95% CI: −1.11 to −0.37, Z=−3.935, P=0.000], the 2-day treatment efficacy for diarrhea in the probiotics group was greater than that in the control group [odds ratio (OR) =2.12, 95% CI: 1.47-3.05, Z=3.998, P=0.000], and the length of hospital stay in the probiotics group was shorter than that of the control group (SMD =−0.60, 95% CI: −0.74 to −0.47, Z=−8.781, P=0.000). In the subgroup analysis, combined probiotics shortened the duration of diarrhea compared with single probiotic use, and Lactobacillus reuteri and Saccharomyces boulardii had a better therapeutic effect than Lactobacillus rhamnosus or Lactobacillus acidophilus.Discussion: In the treatment of acute diarrhea in children, the addition of probiotics can shorten the duration of diarrhea, increase treatment efficacy after 2 days of treatment, and shorten the length of hospital stay. However, because of possible publication bias in the current study, further high-quality RCT studies in clinical settings are needed to verify the current results and continue the exploration of this topic.

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A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Saccharomyces boulardii in Infants and Children With Acute Diarrhea

Cited by 18 publications

References 22 publications

Comparison of safety, effectiveness and serum inflammatory factor indexes of Saccharomyces boulardii versus Bifidobacterium triple viable in treating children with chronic diarrhea: a randomized trial

Comparison of safety, effectiveness and serum inflammatory factor indexes of Saccharomyces boulardii versus Bifidobacterium triple viable in treating children with chronic diarrhea: a randomized trial

Saccharomyces boulardii plus azithromycin is superior to azithromycin alone in reducing the duration of diarrhea in children with acute colitis: a double-blind randomized placebo-controlled trial

Efficacy of probiotics in the treatment of acute diarrhea in children: a systematic review and meta-analysis of clinical trials

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