Impact of Teduglutide on Pediatric Short Bowel Syndrome: Protocol for a Systematic Review and Trial Sequential Meta-Analysis

Background Although studies have evaluated the safety and efficacy of GLP drugs in adult patients with short bowel syndrome, pediatric applications remain contentious due to developmental divergences in drug response and safety profiles. This meta-analysis aims at systematically evaluating efficacy and safety outcomes of teduglutide in pediatric SBS and providing comprehensive evidence for clinical practitioners and families of affected children. Methods and analysis: Randomized controlled trials (RCTs) and cohort studies comparing teduglutide and placebo or regular treatments in pediatric patients with a confirmed diagnosis of short bowel syndrome will be included. Literature searches will be conducted in PubMed, Web of Science, Embase, and Cochrane Library. Two reviewers independently perform the processes of literature retrieval, screening, data extraction, and assessment of risk of bias. Risk of bias in included studies is evaluated using Revised Cochrane risk-of-bias tool (ROB 2) for RCTs and Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-1) for non-RCTs. Review Manager (RevMan) was used for data pooling. Subgroup analysis, meta-regression, trial sequential analysis (TSA), and sensitivity analysis are conducted. Ethics and dissemination: Ethical approval is not required because this study is a secondary analysis of existing data. We will disseminate the findings through peer- reviewed publications. PROSPERO registration number: CRD420251047221