Objective: To determine if Lactobacillus GG (LGG) is an effective adjunct to lactulose for treating constipation in children. Study design: Eighty- four chi ldren (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, randomiz ed placebo- controlled trial in which they received 1 mL/kg/day of 70% lactul ose plus 109 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 intenti on- to- treat basis. Results: Treatment success, defined as ≥ 3 spontaneous B Ms per week with no fecal soiling, was similar in the control and experimental g roups 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 di d not differ in their mean number of spontaneous BMs per week or episodes of fec al 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.
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