Effectiveness and safety of lactobacilli in children with functional constipation: Study protocol for a meta-analysis and systematic review

BACKGROUND: Constipation is one of the most common diseases in children and it is also a significant healthcare burden, more than many other common childhood diseases. For some children, 1st-line treatment cannot relieve their constipation and their constipation symptoms maybe continue to adolescence. So, alternative treatment options such as lactobacilli are needed. However, the effectiveness and safety of lactobacilli is still unclear. To investigate this question, we conduct a systematic review and meta-analysis. METHODS: The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Three main databases (PubMed, Embase, and the Cochrane Library) will be searched to December 20, 2018 for randomized controlled trials investigating the effects and safety of lactobacilli for constipation in children with no language restrictions. In addition, a manual search of the references of relevant published studies will also be considered. Two independent reviewers will conduct studies selection, data extraction, and risk of bias assessment. The primary outcome is defecation frequency, treatment success (bowl movement >3 times per week). The 2nd outcome is stool consistency, incidence of abdominal pain, patients using laxatives, and adverse events. RESULTS: The results will provide useful information about the effect and safety of lactobacilli for constipation in children. CONCLUSION: The findings of this study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42019125913