Impact of a probiotic chewable tablet on stool habits and microbial profile in children with functional constipation: A randomized controlled clinical trial

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 x 10(9) CFU/day, n = 47), consisting of Lactobacillus acidophilus DDS-1 (R) and Bifidobacterium animalis subsp. lactis UABla-12 (TM) 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 (R) and B. Lactis UABla-12 (TM) as a daily probiotic dosage form for children with FC.