The effects of LactoCare synbiotic administration on chemotherapy-induced nausea, vomiting, diarrhea, and constipation in children with ALL: A double-blind randomized clinical trial.

ABSTRACT

BACKGROUND: Synbiotics are supplements containing probiotics and prebiotics and potentially have a stronger effect in modulating the gut microbiota than probiotics or prebiotics alone. The aim of this study was to determine the effects of LactoCare synbiotic administration on chemotherapy-induced diarrhea (CID), nausea, vomiting, and constipation in children with acute lymphoblastic leukemia (ALL) who receiving maintenance chemotherapy. METHODS: This double-blind clinical trial was performed on 113 children with ALL. The patients were randomly assigned into two groups to receive either 5 × 109 CFU LactoCare synbiotic administration or placebo (58 patients in the LactoCare-treatment group and 55 patients in the placebo group), twice a day for 7 days. The number of times CID, vomiting, nausea, and constipation were recorded in the first week after the beginning of receiving LactoCare and the placebo. RESULTS: In the LactoCare-treatment group, CID was present in 3.7% and 1.8% of patients on the first and second days, respectively, and no CID was observed on the third to seventh days (p < .05). While in the placebo group, the rate of patients with CID on the second, third, and fourth days was 11.5%, 13.5%, and 11.5%, respectively, and less than 10% on the first, fifth, sixth, and seventh days. It was observed that the rate of constipation in the LactoCare-treatment group was significantly lower than in the placebo group. The difference between the groups was about 14% on the third day, which increased to about 20% on the sixth day (p < .05). CONCLUSION: The use of synbiotic supplements in this study reduced CID in patients. This study supports the concept that the use of synbiotic supplements will be an easy and effective way to reduce CID in ALL patients.