Objective To discuss the curative effect and safety of Clostridium butyricum Powder combined with Lactulose Oral Solution on functional constipation(FC) in children.Methods 84 cases of FC were divided into observation group and control group at random.The children in the two groups were given routine medical treatments,such as diet adjustment,drinking plenty of water,regular defecation,and exercise for strengthening the defecation function etc.The children in observation group were additionally given Clostridium butyricum Powder combined with Lactulose Oral Solution,while the children in control group were additionally given pure Lactulose Oral Solution for 6 weeks.The clinical curative effect and drug adverse reactions(DARs) of children in two groups after medical treatment was observed,and the reoccurrence rates after following up for 6 months and 1 year were compared.Results After 6 weeks' medical treatment,the total efficiency in children of observation group was 92.86%,which was much higher than that of control group(76.19%)(χ2= 4.46,P 0.05).4 and 2 cases of untoward effect appeared in observation group and control group respectively during the medical treatment with mild symptoms.No statistical differences were observed in the untoward effects between the two groups(χ2= 0.14,P 0.05).Conclusion Compared with pure Lactulose Oral Solution,Clostridium butyricum Powder combined with Lactulose Oral Solution has more favorable curative effects on children with FC,with satisfactory safety,which can reduce the reoccurrence rate.