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Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation:
Dan Gan1, Jialun Chen1, Xin Tang1
1Sirio Pharma Co., Ltd., Shantou, China.
Insights
A probiotic chewable tablet containing Lactobacillus acidophilus DDS-1® and Bifidobacterium animalis subsp. lactis UABla-12™ improved stool frequency and consistency in children with functional constipation (FC). This study highlights the potential of probiotics for managing childhood constipation.
Area of Science:
- Pediatrics
- Gastroenterology
- Microbiology
Background:
- Childhood functional constipation (FC) is a common, multifactorial condition.
- Clinical management of FC in children presents significant challenges.
- Rome III criteria define functional constipation in pediatric populations.
Purpose of the Study:
- To evaluate the efficacy of a specific probiotic formulation in managing childhood functional constipation.
- To assess the impact of the probiotic on stool frequency and consistency.
- To compare the effects of the probiotic chewable tablet against a placebo.
Main Methods:
- A randomized, single-blind, placebo-controlled, multi-center trial.
- Involved 92 children aged 4-12 diagnosed with FC.
- Participants received either a probiotic (Lactobacillus acidophilus DDS-1® and Bifidobacterium animalis subsp. lactis UABla-12™) or placebo twice daily for 4 weeks.
Main Results:
- The probiotic group exhibited a faster and more significant normalization of stool frequency compared to the placebo group.
- A notable decrease in hard stools (from 43% to 14%) was observed in the probiotic group.
- An increase in normal defecation (from 56% to 80%) was recorded in children receiving the probiotic.
Conclusions:
- The probiotic chewable tablet containing L. acidophilus DDS-1® and B. Lactis UABla-12™ demonstrated efficacy in treating childhood functional constipation.
- This probiotic formulation shows potential as a daily therapeutic option for pediatric FC.
- The study supports the use of targeted probiotics for normalizing bowel habits in children.
Abstract:
Constipation is a common and typically multifactorial childhood complaint, and the clinical management of childhood functional constipation (FC) is challenging. A randomized, single-blind, placebo-controlled, multi-center clinical trial was conducted in 92 children (47 from Beijing, China and 45 from Shanghai, China) aged 4-12 with FC according to Rome III criteria. Children were assigned to receive a probiotic chewable tablet (5 × 109 CFU/day, n = 47), consisting of Lactobacillus acidophilus DDS-1® and Bifidobacterium animalis subsp. lactis UABla-12™ or placebo (n = 45), twice daily for 4 weeks, followed by a week follow-up period. Results suggested that the probiotic group showed a faster and more pronounced normalization of stool frequency over the intervention period (3.15 vs. 1.83) when compared to placebo group (2.51 vs. 1.87). Meanwhile, the percentage of subjects with hard defecation decreased from 43 to 14% in the probiotic group, while the percentage of subjects with normal defecation increased from 56 to 80% in the probiotic group, further confirming the normalization of stools habits. This randomized controlled trial demonstrated the potential of a probiotic chewable tablet containing L. acidophilus DDS-1® and B. Lactis UABla-12™ as a daily probiotic dosage form for children with FC.
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