GNN was

as effective as placebo in achieving therapeutic success in constipated children [8]. In the second, multicenter, 2-nation (The Netherlands and Poland) trial (n = 159) [9], children aged 3–16 years with functional constipation according to the Rome III criteria were randomly allocated to receive a fermented dairy product with Bifidobacterium lactis I-2494 (B. lactis) twice daily for 3 weeks or a comparable placebo. The effectiveness of the experimental treatment was comparable to that of the placebo [9]. Follow-up data were collected using a standardized questionnaire at 24 months after completion of the GNN study and at 36 months after completion of the B. lactis study. Participants were contacted by phone or regular mail. The questions asked related to the frequency, size, and consistency of stools defecated into the toilet, the presence of abdominal pain, and Natural Product Library order the need for laxative therapy. The primary outcome measure was treatment success, defined as ≥3 spontaneous bowel movements with no episodes of soiling during the last week, no abdominal pain, and no need for laxative treatment. The secondary outcomes were functional constipation according to the Rome III criteria and the need for laxative treatment. The computer software Stats Direct [version 2.7.9.(2012-07-09)] was used to calculate the relative risk (RR) and mean difference (MD), both with a 95%

Smad inhibitor CI. The difference between study groups was considered significant when the p value was <0.05, when the 95% CI for RR did not include 1.0, or when the 95% CI for MD did not include 0. All statistical tests were two tailed and performed at the 5% level of significance. The baseline characteristics of the 2 included populations [8] and [9] are summarized in Table I. The primary and secondary outcomes are summarized in Table II. In the GNN study, follow-up data at 24 months were obtained from 63 of 72 (87.5%) of the children. Overall, treatment success was reported in 36 of 63 (57%) of the children, and there was Staurosporine supplier no difference in treatment success rates between the GNN and placebo groups (RR 1.08, 95% CI 0.70 to 1.66).

Functional constipation was reported in 17 of 63 (27%) of the children; the rate did not differ between groups (RR 0.86, 95% CI 0.38 to 1.94). The need for laxatives was reported in 13 of 63 (21%) of the children; the rate was similar in both groups (RR 0.83, 95% CI 0.31 to 2.20). The mean age of children with constipation was higher than that of children with treatment success, although the difference was of borderline statistical significance (9.7 ± 3.19 vs. 7.83 ± 3.4 years; MD 1.87, 95% CI −0.01 to 3.75). In the B. lactis study, only a subset of 76 children enrolled in Poland was invited to participate in the present follow-up. Follow-up data at 36 months were obtained from 57 of 82 (70%) of the children ( Table II). Treatment success was achieved in 26 of 57 (46%) of the children, and the rate did not differ between the B.