Fecal microbiota transplantation for the treatment of neurogenic rosacea: protocol of a randomized, blinded, placebo-controlled explorer study.

Abstract

Neurogenic rosacea is a distinct phenotype of rosacea characterized by persistent facial erythema, flushing, burning, and stinging, and it often responds poorly to conventional therapies. Increasing evidence suggests that gut microbiota dysbiosis may be involved in the pathogenesis of NR. Fecal microbiota transplantation may provide a novel therapeutic strategy by restoring microbial homeostasis. This study aims to evaluate the efficacy and safety of FMT in patients with NR and to explore its potential mechanisms through modulation of the gut microbiota. This is a single-center, randomized, double-blind, placebo-controlled exploratory trial. Sixty patients with NR will be randomly assigned (1:1) to receive either FMT capsules or placebo capsules for 3 consecutive weeks and followed for 12 weeks. The primary outcome is the proportion of participants achieving CEA success at week 12, defined as a CEA score of 0 or 1 or a reduction of ≥2 grades from baseline. Secondary outcomes include flushing severity, symptom scores, quality of life, psychological status, objective erythema index, and safety. Exploratory analyses will assess gut microbiota composition, fecal and serum metabolomics, and neurovascular-related cytokines. This study is the first clinical trial to explore the effects of fecal microbiota transplantation in the treatment of neurogenic rosacea. The trial may provide clinical evidence for the application of fecal microbiota transplantation as a novel therapeutic strategy for refractory neurogenic rosacea. Chinese Clinical Trial Registry (ChiCTR2500109957) on September 28, 2025.