Bacillus spore probiotics for alleviating functional constipation in children: a randomized, double-blind, placebo-controlled trial

TL;DR

Bacillus spore probiotics significantly improved constipation, appetite, and weight in young children, suggesting they could be an effective treatment for functional constipation.

Contribution

This is the first randomized, double-blind, placebo-controlled trial demonstrating the efficacy of multi-strain Bacillus spore probiotics in treating functional constipation in children.

Findings

Both probiotic groups showed a 3.7- to 5.1-fold reduction in constipation compared to placebo.

Probiotics improved immune markers like IL-6, IL-23, IL-10, and stool IgA.

Gut microbiota shifted toward a healthier composition resembling that of healthy children.

Abstract

Functional constipation is common in children and often responds poorly to standard treatments. This study evaluated the efficacy and mechanisms of multi-strain Bacillus spore probiotics, which tolerate gastrointestinal conditions, in paediatric functional constipation.

We conducted a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov NCT06154525, 4/12/2023) in preschool children (24–60 months) with functional constipation in Vietnam. A total of 111 participants were randomly assigned (1:1:1) to receive placebo or two multi-strain Bacillus spore probiotics (LiveSpo Kids or Preg-Mom, ≥3 billion CFU/5 mL registered; each tested at 3.7 billion CFU/5 mL) for 28 days. Primary outcomes were changes in functional constipation (main focus), anorexia, and underweight risk at day 28. Secondary outcomes included serum cytokines, stool IgA, and gut microbiota; stool samples from 10 healthy children provided a reference microbiota profile.

Both probiotic groups show significant improvements at day 28. Percentages of children with constipation decrease 3.7-fold in Kids and 5.1-fold in PregMom (p < 0.0001). Absolute Risk Reductions (ARR) are 52.38% (95%CI: 35.45%-77.26%) and 59.97% (95%CI: 44.48%-84.68%) in Kids and PregMom vs Placebo. Kids and PregMom groups improve anorexia (ARR: 24.40% (95%CI: 3.09%-49.44%) and 25.98% (95%CI: 4.69%-51.25%)) and underweight risk (ARR: 7.87% (95%CI: 0%-23.80%) and 19.30% (95%CI: 1.70%-37.50%)) vs. Placebo. Probiotics reduce serum IL-6 and IL-23, increase IL-10 and stool IgA, and shift the gut microbiota toward a composition more closely resembling healthy children, enriching beneficial species while reducing harmful ones.

Multi-strain Bacillus spore probiotics alleviate functional constipation, improve immune markers, and modulate gut microbiota in children, supporting their potential as effective microbiome-targeted interventions.

Constipation is common in young children, leading to infrequent and painful bowel movements. Probiotics are live microorganisms that can provide health benefits when consumed, primarily by improving the composition of microorganisms within the gut. Bacillus spore probiotics can survive harsh gastrointestinal conditions, allowing them to reach the gut and act effectively. We tested two multi-strain Bacillus spore probiotics, LiveSpo Kids and Preg-Mom, in children aged 24 to 60 months with constipation. After drinking these probiotics twice daily for four weeks, children had significantly better bowel movements than those given water. They also showed better appetite and healthier weight gain. We propose these probiotics may be a safe and effective approach to treat childhood constipation, especially in areas with limited access to specialized medical care.

Nguyen et al. conduct a randomized, double-blind, controlled clinical trial evaluating multi-strain Bacillus spore probiotics for treating functional constipation in preschool children. The probiotics significantly reduce constipation, anorexia, and underweight risk and improve immune markers and gut microbiota composition after 7–28 days of use.

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