Efficacy of Bacillus clausii in Pediatric Functional Constipation: A Pilot of a Randomized, Double-Blind, Placebo-Controlled Trial.

2023-02-09
Indian pediatrics 60(6)
- Ponlakit Lojanatorn
- Jirachart Phrommas
- Pornthep Tanpowpong
- Songpon Getsuwan
- Chatmanee Lertudomphonwanit
- Suporn Treepongkaruna

PubMed: 36757002
DOI: 10.1007/s13312-023-2907-0

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 38
Population: children aged 1-5 years diagnosed with functional constipation according to Rome IV criteria
Methods: randomized, double-blind, placebo-controlled trial; assigned to receive either B. clausii or placebo, once daily for four weeks
Blinding: Double-blind
Duration: four weeks
Funding: Unclear

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.

Conclusions

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.

Research Insights

Bacillus clausii→Improved Bowel Movement Frequency
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.
Effect
Neutral
Effect size
Small
Dose
once daily for four weeks
Bacillus clausii→Improved Stool Consistency
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.
Effect
Neutral
Effect size
Small
Dose
once daily for four weeks
Bacillus clausii→Increased Treatment Success Rate
no significant difference was noted in the treatment success between B. clausii and placebo groups [45% vs 56%; P=0.52]
Effect
Neutral
Effect size
Small
Dose
once daily for four weeks
Bacillus clausii→Reduced Painful Defecation
The frequency of painful defecation and large fecal mass were also significantly decreased in both the groups.
Effect
Neutral
Effect size
Small
Dose
once daily for four weeks
Bacillus clausii→Reduced Stool Volume
The frequency of painful defecation and large fecal mass were also significantly decreased in both the groups.
Effect
Neutral
Effect size
Small
Dose
once daily for four weeks

Adverse Events Reported

Bacillus clausii→Overall tolerability
No serious adverse events were observed.
Finding
Reported