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

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.