Objectives To evaluate the effect and safety of Xiao Er Fu Xie Tie in children with acute diarrhea. Methods A multicenter, randomized, open-label, active-controlled clinical trial was carried out in three hospitals from March 2011 to December 2012. Children with acute diarrhea were enrolled and divided randomly into two groups, the observation group (treated with Xiao Er Fu Xie Tie) and the control group (treated with smectite powder). Boths groups received oral rehydration salts treatment. Symptoms and signs were recorded before and after therapy. The therapeutic effect was evaluated at 3 and 5 days after therapy. All of the adverse drug reactions were recorded during the study. Results In 197 children who completed the study, 100 children received Xiao Er Fu Xie Tie and 97 received smectite powder. Both groups were similar in age and gender distribution, weight, duration and frequency of diarrhea, times of vomiting, degree of dehydration and so on (P>0.05). After therapy, effective rates of the observation group at 3 days (97%) and 5 days (100%) were similar to those of control group (P>0.05). The effective rate for relieving vomiting in the observation group was higher than that in control group (P<0.05). No obvious adverse drug reactions were found during the study. Conclusions Xiao Er Fu Xie Tie has the same effect as smectite powder for treatment of acute diarrhea in children and is more effective in vomiting. Furthermore, no obvious adverse drug re-actions were found.

To discuss clinical diagnosis and treatment of cow’s milk protein allergy and cow’s milk protein-induced FPIES (food protein induced enterocolitis syndrome). Methods We retrospectively analyzed clinical data of one infant with milk protein allergy-induced FPIES. Results A 67 days old female on mixed breast and formula feeding developed recurrent diarrhea, abdominal distension, vomiting, mucousy and bloody stools, feeding dififculty, anemia, and failure to thrive since 2 weeks after birth. Laboratory studies showed anemia, increased CRP level and elevation of peripheral white blood count and eosinophil proportion. Milk-speciifc IgE was negative. She was previously hospitalized 4 times, all with admitting diagnosis of“necrotizing enterocolitis”. We treated her with milk protein elimination for 4 weeks and all symptoms were resolved. Milk protein re-challenge test was positive, consistent with clinical features of cow’s milk protein allergy-induced infant FPIES. Conclusions Cow’s milk protein allergy and cow’s milk protein-induced FPIES can present with non-speciifc and variable clinical symptoms and signs, and should be considered in the differential diagnosis.