Ineffectiveness of Lactobacillus GG as an adjunct to lactulose for the treatment of constipation in children:: A double-blind, placebo-controlled randomized trial

Objective To determine if LactobacillusGG (LGG) is an effective adjunct to lactulose for treating constipation in children. Study design Eighty-four children (2-16 years of age) with constipation (< 3 spontaneous bowel movements [BMs] per week for at least 12 weeks) were enrolled in a double-blind, randomized placebo-controlled trial in which they received 1 mL/kg/day of 70% lactulose plus 10(9) colony-forming units (CFU) of LGG (experimental group, n = 43) or a placebo (control group, n = 41) orally twice daily for 12 weeks. The primary outcome measure was treatment success. and analyses were performed on an intention-to-treat basis. Results Treatment success, defined as >= 3 spontaneous BMs per week with no fecal soiling, was similar in the control and experimental groups at 12 weeks (28/41[68%] vs 31/43 [72%], respectively; P = .7) and at 24 weeks (27/41 [65%] vs; 27/42 [64%], respectively; P = 1.0). Groups also did not differ in their mean number of spontaneous BMs per week or episodes of fecal soiling per week at 4, 8, and 12 weeks. Adverse events and overall tolerance did not differ between groups. Conclusion LGG, as dosed in this study, was not an effective adjunct to lactulose in treating constipation in children.