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Saccharomyces boulardii and Lactulose for Childhood Functional Constipation: A Multicenter Randomized Controlled Trial

Authors
Lee, Kyung JaeRyoo, EellLee, Yoo MinYoon, Jung MinJang, Hyo-JeongChoi, So YoonChoi, You JinKim, Hyun JinChung, Ju YoungShim, Jung Ok
Issue Date
Jul-2022
Publisher
대한소화기 기능성질환∙운동학회
Keywords
Constipation; Microbiota; Pediatrics; Probiotics
Citation
Journal of Neurogastroenterology and Motility (JNM), v.28, no.3, pp.454 - 462
Indexed
SCIE
SCOPUS
KCI
Journal Title
Journal of Neurogastroenterology and Motility (JNM)
Volume
28
Number
3
Start Page
454
End Page
462
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/61249
DOI
10.5056/jnm21130
ISSN
2093-0879
Abstract
Background/Aims The effects of probiotics in children vary based on diseases and probiotic strains. We aim to investigate the effectiveness of Saccharomyces boulardii and lactulose for treating childhood functional constipation. Methods This open-label randomized controlled trial was conducted at 10 university hospitals in Korea. Children who were diagnosed with functional constipation were allocated to 3 groups (lactulose monotherapy, combination therapy, and S. boulardii monotherapy). The primary outcome was treatment success rate that was accordingly defined as ≥ 3 bowel movements without incontinence at week 12. The cumulative successful maintenance and drug maintenance rates without drug changes were calculated throughout the study period. We compared stool frequency, incontinence, consistency, and painful defecation at week 2 among the 3 groups. Results Overall, 187 children were assigned to the lactulose monotherapy (n = 69), combination therapy (n = 68), or S. boulardii monotherapy (n = 50) groups. The primary outcome was significantly higher in the lactulose monotherapy group (26.1%) or combination therapy group (41.2%) than in the S. boulardii monotherapy group (8.0%). The S. boulardii monotherapy group showed a significantly lower cumulative successful maintenance and drug maintenance rate than the other 2 groups. There were no significant intergroup differences in the frequency of defecation, incontinence, painful defecation, or stool consistency during the follow-up at week 2. Conclusion S. boulardii monotherapy was not superior to lactulose monotherapy or combination therapy and showed a higher drug change rate, supporting the current recommendation of probiotics in the treatment of childhood functional constipation.
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