Efficacy and Safety of Fecal Microbiota Transplantation for Patients with Treatment-resistant Schizophrenia: A Double-blind, Randomized Clinical Trial Protocol

OBJECTIVES: This randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy and safety of Fecal Microbiota Transplantation (FMT) in patients with Treatment-Resistant Schizophrenia (TRS), comparing two delivery methods: intraduodenal administration via gastroscopy and oral capsule ingestion. METHODS: This study employed a randomized, double-blind, placebo-controlled design. Eligible subjects will be randomized into three groups: (1) intraduodenal FMT administration via gastroscopy, (2) oral FMT capsule administration, and (3) placebo control. Before and after the intervention, fecal, urine, and venous blood samples will be collected for microbiomics and metabolomic analyses. Clinical symptom severity will be assessed using standardized psychiatric scales to evaluate the efficacy and safety of FMT. DISCUSSION: Should Fecal Microbiota Transplantation be found to be as clinically and cost-effective for patients with treatment-resistant schizophrenia, this approach has the potential to be considered as an adjunctive treatment for those with a broader range of psychiatric conditions. CLINICAL TRIAL REGISTRATION NUMBER: ChiCTR2400092799.