The study evaluated two liquid probiotic supplements, namely LiveSpo Kids which contains Bacillus clausii ANA39 and B. subtilis ANA3 and LiveSpo Preg-Mom, which contains B. clausii ANA39, B. subtilis ANA46 and B. coagulans ANA40. Both are manufactured by LiveSpo Pharma in Vietnam.
Published in Communications Medicine, the findings showed improved bowel movements, appetite, healthier weight gain and a reduction in inflammatory markers in the probiotic groups as compared to the placebo group.
Study cohort and probiotic formulation
Researchers recruited 111 pre-school children aged 24 to 60 months diagnosed with functional constipation, a condition characterised by infrequent or difficult bowel movements with abdominal discomfort, which can impair growth if untreated.
The children were randomised to take either the placebo or LiveSpo Preg-Mom or LiveSpo Kids twice daily. The probiotic formulations were labelled containing more than three billion CFU per five mL ampoule.
The primary objectives were to find out if Bacillus spore probiotics supplementation could reduce constipation and the risk of being underweight. Constipation was defined as having less than two bowel movements per week, straining and withholding behaviours, or hard and larger stools.
Blood and stool samples were also collected to measure changes in secondary outcomes, including serum cytokine levels and stool IgA.
Easing constipation, support appetite
Both probiotic groups saw a significant decrease in the proportion of children with constipation after the first week of supplementation, with more pronounced improvements on day 28.
Specifically, the percentage of children with two or fewer bowel movements per week was down by 3.60-fold and 4.00-fold in the LiveSpo Kids and the LiveSpo Preg-Mom groups, respectively, on day 28.
During this time, the placebo group saw a non-significant decrease of 1.25-fold.
Researchers attributed the statistically non-significant improvements in the placebo group to dietary and hydration advice provided to all participants at baseline. The advice included increasing their fiber intake, staying hydrated, and limiting constipating foods.
“In conclusion, LiveSpo Preg-Mom, and to a less extend LiveSpo Kids, efficiently alleviated constipation, with effects observed as early as after 7 days of use,” the researchers wrote.
Other benefits seen
In addition to relieving constipation, children on probiotics also showed improved appetite and healthier weight gain.
By day 28, the LiveSpo Preg-Mom group showed significant improvements in appetite-related signs. For example, they showed better appetite and ate faster, with meal times of less than 30 minutes.
Both probiotic groups also gained weight - 0.30 kg - as compared to no weight gain in the placebo group.
The proportion of children at risk of being underweight also decreased in both probiotic groups, although the decline was only statistically significant in the group taking LiveSpo Preg-Mom.
Possible mucosal protection
The study also reported a significant decrease in pro-inflammatory markers of IL-6 and IL-23 levels at day 28 in both probiotic groups.
The amount of IL-17, another pro-inflammatory cytokine, remained unchanged in both probiotic groups, but was significantly higher in the placebo group.
Alongside, there was an increase in the anti-inflammatory cytokine IL-10 and stool IgA in both probiotic groups. The placebo group reported a non-significant decrease in IL-10, and a non-significant change in IgA.
“Our study found a significant induction of fecal IgA by probiotics as early as day seven, suggesting an enhanced mucosal protection,” the researchers wrote.
“(The) Increased Th2-driven IgA production may strengthen mucosal barrier protection by stabilising the mucus layer and reducing local inflammation, while modulation of Th17-associated cytokines (reduced IL-6, IL-17, IL-23 and increased IL-10) indicates a shift toward an anti-inflammatory milieu. Together, these changes could improve intestinal function and contribute to the observed relief of constipation symptoms,” they added.
Promising intervention for functional constipation
This short RCT showed that children who drank the liquid probiotics twice daily for four weeks had better constipation relief, appetite, weight gain, and reduced underweight risk, with greater effects observed in the LiveSpo Preg-Mom group, followed by LiveSpo Kids.
During the course of the intervention, no adverse reactions were reported in the probiotic groups.
As such, the researchers proposed that these probiotics may be a safe and effective approach to treat childhood constipation, especially in areas with limited access to specialised medical care.
Given the current study was conducted for 28 days, they recommended that future studies should include longer follow-up periods and larger cohorts to further assess sustained efficacy and long-term outcomes.
Functional constipation affects up to 14% of children worldwide, and current treatments include diet, behavioural therapy, and laxatives, which only provide temporary relief.
“Given the rapid onset of symptom relief observed by day seven, these Bacillus-based probiotics may represent a promising alternative or adjunct to conventional laxatives in primary care, particularly for children with recurrent symptoms or intolerance to pharmacological options,” researchers concluded.
Source: Communications medicine, 6(1), 148. doi: 10.1038/s43856-026-01517-6. “Bacillus spore probiotics for alleviating functional constipation in children: a randomized, double-blind, placebo-controlled trial.” Authors: Nguyen, H. T. L. et al.
