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布拉氏酵母菌散剂治疗婴幼儿急性腹泻的多中心、随机、双盲、安慰剂对照临床研究

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

机构信息

From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.

Sundyota Numandis Probioceuticals Pvt. Ltd.

出版信息

Pediatr Infect Dis J. 2020 Nov;39(11):e347-e351. doi: 10.1097/INF.0000000000002849.

DOI:10.1097/INF.0000000000002849
PMID:32796401
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7556239/
Abstract

AIM

This study was designed to assess the efficacy and safety of Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799) in the management of acute diarrhea in children.

METHODS

A total of 100 infants and children 3-36 months of age with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children and were randomly allocated to the probiotic group (S. boulardii CNCM I-3799 at a daily dose of 5 billion CFU twice daily) or to the placebo group. Infants and children were treated for 5 days and an extended follow-up was planned 1 and 2 months after the end of the treatment period. Primary endpoint was the time of recovery from diarrhea defined as the duration of diarrhea. Other parameters, such as frequency and consistency of stools, associated with the severity of diarrhea episodes were defined as secondary endpoints.

RESULTS

The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea. The time of recovery from diarrhea was significantly shorter in the probiotic group compared with the placebo group (65.8 ± 12 hours vs. 95.3 ± 17.6 hours, P = 0.0001). Faster remission in the probiotic group was also demonstrated by a shorter time before the first episode of semisolid stool [-23.5 hours, diff (95% CI): -7.99 (-31.49 to -15.51), P = 0.0001] and the faster normalization of stool consistency. S. boulardii CNCM I-3799 was well tolerated.

CONCLUSION

S. boulardii CNCM I-3799 supplementation in children with acute diarrhea was shown effective in reducing the duration and severity of diarrhea in infants and children.

摘要

目的

本研究旨在评估酿酒酵母变异株 boulardii CNCM I-3799(S. boulardii CNCM I-3799)在儿童急性腹泻管理中的疗效和安全性。

方法

共有 100 名年龄在 3-36 个月的急性腹泻婴儿和儿童根据世界卫生组织关于儿童急性腹泻管理的指南接受医疗护理,并随机分配到益生菌组(S. boulardii CNCM I-3799,每日剂量为 50 亿 CFU,每日两次)或安慰剂组。婴儿和儿童接受 5 天的治疗,并计划在治疗结束后 1 个月和 2 个月进行延长随访。主要终点是腹泻恢复时间,定义为腹泻持续时间。其他参数,如粪便的频率和稠度,与腹泻发作的严重程度相关,定义为次要终点。

结果

给予 S. boulardii CNCM I-3799 对腹泻的持续时间和严重程度有有益影响。益生菌组腹泻恢复时间明显短于安慰剂组(65.8 ± 12 小时 vs. 95.3 ± 17.6 小时,P = 0.0001)。益生菌组在首次出现半固体粪便前的时间也更快缓解[-23.5 小时,差异(95%CI):-7.99(-31.49 至-15.51),P = 0.0001],粪便稠度更快恢复正常,表明更快缓解。S. boulardii CNCM I-3799 耐受良好。

结论

在急性腹泻的儿童中补充 S. boulardii CNCM I-3799 可有效降低婴儿和儿童腹泻的持续时间和严重程度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/44fef803aea2/inf-39-e347-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/4df6d267356b/inf-39-e347-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/b6ca515fc592/inf-39-e347-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/44fef803aea2/inf-39-e347-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/4df6d267356b/inf-39-e347-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/b6ca515fc592/inf-39-e347-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a57/7556239/44fef803aea2/inf-39-e347-g003.jpg

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