Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial
Issued Date
2023-06-01
Resource Type
ISSN
00196061
eISSN
09747559
Scopus ID
2-s2.0-85162648064
Pubmed ID
36757002
Journal Title
Indian Pediatrics
Volume
60
Issue
6
Start Page
453
End Page
458
Rights Holder(s)
SCOPUS
Bibliographic Citation
Indian Pediatrics Vol.60 No.6 (2023) , 453-458
Suggested Citation
Lojanatorn P., Phrommas J., Tanpowpong P., Getsuwan S., Lertudomphonwanit C., Treepongkaruna S. Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial. Indian Pediatrics Vol.60 No.6 (2023) , 453-458. 458. doi:10.1007/s13312-023-2907-0 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/87790
Title
Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial
Author's Affiliation
Other Contributor(s)
Abstract
Purpose: To evaluate the efficacy of Bacillus clausii in the treatment of pediatric constipation. Methods: A randomized, double-blind, placebo-controlled trial was conducted from January, 2021 to January, 2022 in children aged 1–5 years diagnosed with functional constipation according to Rome IV criteria. They were assigned to receive either B. clausii or placebo, once daily for four weeks. The primary out-come was treatment success (defined as ≥3 spontaneous stools per week and stool consistency grade ≥3 on Bristol stool chart). The secondary outcome was a comparison of stool frequency, consistency (defined by Bristol stool grade), and constipation-related symptoms. Results: This trial enrolled 38 children (B. clausii, n=20 and placebo, n=18). At 4 weeks, no significant difference was noted in the treatment success between B. clausii and placebo groups [45% vs 56%; P=0.52). On within-group analyses, the mean (SD) of Bristol stool grade increased in both the B. clausii [1.7 (0.5) to 2.8 (1.2); P=0.003] and placebo [1.8 (0.5) to 2.8 (1.2); P=0.01] groups. Significant increases in the treatment success rate (22% to 56%, P=0.01) and mean stool frequency per week [3 (0.9) to 4.2 (1.7), P=0.01] were pronounced only in the placebo group. The frequency of painful defecation and large fecal mass were also significantly decreased in both the groups. No serious adverse events were observed. Conclusion: A 4-week course of B. clausii as the sole treatment was not more effective than a placebo for the management of functional constipation in children aged 1–5 years.