BACKGROUND: The purpose of the present paper was to evaluate the efficacy of probiotics (Lactobacillus casei rhamnosus, Lcr35) for treating children with chronic constipation and to compare its effect with magnesium oxide (MgO) and placebo. METHODS: This double-blind placebo-controlled, randomized study enrolled 45 children under 10 years old with chronic constipation. They were randomly assigned to receive Lcr35 (8 x 10(8) c.f.u./day; n = 18), MgO (50 mg/kg/day; n = 18), or placebo (n = 9) orally twice daily for 4 weeks. Lactulose use (1 mL/kg per day) was allowed when no stool passage for 3 days was noted. Glycerin enema was used only when no defecation was noted for >5 days or abdominal pain was suffered due to stool impaction. Bacterial cultures of stool were performed before and after treatment to evaluate the change of intestinal flora. Comparisons of the frequency of defecation, consistency of stool and the use of lactulose or enema during the period of treatment were made among the three groups. RESULTS: The patients who received MgO or probiotics had a higher defecation frequency (P = 0.03), higher percentage of treatment success (P = 0.01), less use of glycerin enema (P = 0.04) and less hard stool (P = 0.01) than the placebo group. There was no significant difference between MgO and probiotic groups in the aforementioned comparisons. The first effect of MgO (second week) on constipation was slightly earlier than that of probiotic (second to third week). Abdominal pain occurred less frequently in the probiotic group than in both the MgO and the placebo groups (P = 0.03). There was no statistically significant difference among the three groups in the use of lactulose, episodes of fecal soiling, and change of appetite. No adverse effect was noted in probiotic and placebo groups. Only one patient in the MgO group suffered from mild diarrhea. CONCLUSION:Lcr35 was effective in treating children with chronic constipation. There is no statistically significant difference in efficacy between MgO and Lcr35, but less abdominal pain occurred when using Lcr35. Study with larger case number and longer follow up is needed in the future.
RCT Entities:
BACKGROUND: The purpose of the present paper was to evaluate the efficacy of probiotics (Lactobacillus casei rhamnosus, Lcr35) for treating children with chronic constipation and to compare its effect with magnesium oxide (MgO) and placebo. METHODS: This double-blind placebo-controlled, randomized study enrolled 45 children under 10 years old with chronic constipation. They were randomly assigned to receive Lcr35 (8 x 10(8) c.f.u./day; n = 18), MgO (50 mg/kg/day; n = 18), or placebo (n = 9) orally twice daily for 4 weeks. Lactulose use (1 mL/kg per day) was allowed when no stool passage for 3 days was noted. Glycerin enema was used only when no defecation was noted for >5 days or abdominal pain was suffered due to stool impaction. Bacterial cultures of stool were performed before and after treatment to evaluate the change of intestinal flora. Comparisons of the frequency of defecation, consistency of stool and the use of lactulose or enema during the period of treatment were made among the three groups. RESULTS: The patients who received MgO or probiotics had a higher defecation frequency (P = 0.03), higher percentage of treatment success (P = 0.01), less use of glycerin enema (P = 0.04) and less hard stool (P = 0.01) than the placebo group. There was no significant difference between MgO and probiotic groups in the aforementioned comparisons. The first effect of MgO (second week) on constipation was slightly earlier than that of probiotic (second to third week). Abdominal pain occurred less frequently in the probiotic group than in both the MgO and the placebo groups (P = 0.03). There was no statistically significant difference among the three groups in the use of lactulose, episodes of fecal soiling, and change of appetite. No adverse effect was noted in probiotic and placebo groups. Only one patient in the MgO group suffered from mild diarrhea. CONCLUSION: Lcr35 was effective in treating children with chronic constipation. There is no statistically significant difference in efficacy between MgO and Lcr35, but less abdominal pain occurred when using Lcr35. Study with larger case number and longer follow up is needed in the future.