ArticleCommunications medicine2026
Bacillus spore probiotics for alleviating functional constipation in children: a randomized, double-blind, placebo-controlled trial.
Article in Communications medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06154525 (Evaluating the Effectiveness of the LiveSpo® Preg-Mom and LiveSpo® KIDS Spore Probiotics in Supporting the Reduction of Constipation, Anorexia, and Slow Weight Gain in Children Aged 24-60 Months), which is not on this map. Not yet cited in PubMed.
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Evaluating the Effectiveness of the LiveSpo® Preg-Mom and LiveSpo® KIDS Spore Probiotics in Supporting the Reduction of Constipation, Anorexia, and Slow Weight Gain in Children Aged 24-60 Months
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10 authors.
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Abstract
backgroundFunctional 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.
methodsWe 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.
resultsBoth 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.
conclusionsMulti-strain Bacillus spore probiotics alleviate functional constipation, improve immune markers, and modulate gut microbiota in children, supporting their potential as effective microbiome-targeted interventions.
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