Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial

Constipation is a common and typically multifactorial childhood complaint, and the clinical management of childhood functional constipation (FC) is challenging. A randomized, single-blind, placebo-controlled, multi-center clinical trial was conducted in 92 children (47 from Beijing, China and 45 fro...

Full description

Bibliographic Details
Main Authors: Dan Gan, Jialun Chen, Xin Tang, Luyao Xiao, Christopher J. Martoni, Gregory Leyer, Guixia Huang, Wei Li
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-08-01
Series:Frontiers in Microbiology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmicb.2022.985308/full
_version_ 1817999066749992960
author Dan Gan
Jialun Chen
Xin Tang
Luyao Xiao
Christopher J. Martoni
Gregory Leyer
Guixia Huang
Wei Li
author_facet Dan Gan
Jialun Chen
Xin Tang
Luyao Xiao
Christopher J. Martoni
Gregory Leyer
Guixia Huang
Wei Li
author_sort Dan Gan
collection DOAJ
description Constipation is a common and typically multifactorial childhood complaint, and the clinical management of childhood functional constipation (FC) is challenging. A randomized, single-blind, placebo-controlled, multi-center clinical trial was conducted in 92 children (47 from Beijing, China and 45 from Shanghai, China) aged 4–12 with FC according to Rome III criteria. Children were assigned to receive a probiotic chewable tablet (5 × 109 CFU/day, n = 47), consisting of Lactobacillus acidophilus DDS-1® and Bifidobacterium animalis subsp. lactis UABla-12™ or placebo (n = 45), twice daily for 4 weeks, followed by a week follow-up period. Results suggested that the probiotic group showed a faster and more pronounced normalization of stool frequency over the intervention period (3.15 vs. 1.83) when compared to placebo group (2.51 vs. 1.87). Meanwhile, the percentage of subjects with hard defecation decreased from 43 to 14% in the probiotic group, while the percentage of subjects with normal defecation increased from 56 to 80% in the probiotic group, further confirming the normalization of stools habits. This randomized controlled trial demonstrated the potential of a probiotic chewable tablet containing L. acidophilus DDS-1® and B. Lactis UABla-12™ as a daily probiotic dosage form for children with FC.
first_indexed 2024-04-14T03:03:02Z
format Article
id doaj.art-b30dc3b4c9a04cf78c2b693a72ffa788
institution Directory Open Access Journal
issn 1664-302X
language English
last_indexed 2024-04-14T03:03:02Z
publishDate 2022-08-01
publisher Frontiers Media S.A.
record_format Article
series Frontiers in Microbiology
spelling doaj.art-b30dc3b4c9a04cf78c2b693a72ffa7882022-12-22T02:15:52ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2022-08-011310.3389/fmicb.2022.985308985308Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trialDan Gan0Jialun Chen1Xin Tang2Luyao Xiao3Christopher J. Martoni4Gregory Leyer5Guixia Huang6Wei Li7Sirio Pharma Co., Ltd., Shantou, ChinaSirio Pharma Co., Ltd., Shantou, ChinaSirio Pharma Co., Ltd., Shantou, ChinaCollege of Food Science and Technology, Nanjing Agricultural University, Nanjing, ChinaChr. Hansen, Windsor, WI, United StatesChr. Hansen, Windsor, WI, United StatesSirio Pharma Co., Ltd., Shantou, ChinaCollege of Food Science and Technology, Nanjing Agricultural University, Nanjing, ChinaConstipation is a common and typically multifactorial childhood complaint, and the clinical management of childhood functional constipation (FC) is challenging. A randomized, single-blind, placebo-controlled, multi-center clinical trial was conducted in 92 children (47 from Beijing, China and 45 from Shanghai, China) aged 4–12 with FC according to Rome III criteria. Children were assigned to receive a probiotic chewable tablet (5 × 109 CFU/day, n = 47), consisting of Lactobacillus acidophilus DDS-1® and Bifidobacterium animalis subsp. lactis UABla-12™ or placebo (n = 45), twice daily for 4 weeks, followed by a week follow-up period. Results suggested that the probiotic group showed a faster and more pronounced normalization of stool frequency over the intervention period (3.15 vs. 1.83) when compared to placebo group (2.51 vs. 1.87). Meanwhile, the percentage of subjects with hard defecation decreased from 43 to 14% in the probiotic group, while the percentage of subjects with normal defecation increased from 56 to 80% in the probiotic group, further confirming the normalization of stools habits. This randomized controlled trial demonstrated the potential of a probiotic chewable tablet containing L. acidophilus DDS-1® and B. Lactis UABla-12™ as a daily probiotic dosage form for children with FC.https://www.frontiersin.org/articles/10.3389/fmicb.2022.985308/fullfunctional constipationmicrobiomeprobiotic chewablechildrenclinical trial
spellingShingle Dan Gan
Jialun Chen
Xin Tang
Luyao Xiao
Christopher J. Martoni
Gregory Leyer
Guixia Huang
Wei Li
Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial
Frontiers in Microbiology
functional constipation
microbiome
probiotic chewable
children
clinical trial
title Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial
title_full Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial
title_fullStr Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial
title_full_unstemmed Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial
title_short Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial
title_sort impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation a randomized controlled clinical trial
topic functional constipation
microbiome
probiotic chewable
children
clinical trial
url https://www.frontiersin.org/articles/10.3389/fmicb.2022.985308/full
work_keys_str_mv AT dangan impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT jialunchen impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT xintang impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT luyaoxiao impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT christopherjmartoni impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT gregoryleyer impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT guixiahuang impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial
AT weili impactofaprobioticchewabletabletonstoolhabitsandmicrobialprofileinchildrenwithfunctionalconstipationarandomizedcontrolledclinicaltrial