Fecal microbiota transplantation for the treatment of neurogenic rosacea: protocol of a randomized, blinded, placebo-controlled explorer study.
- 1Department of Vascular Surgery, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
- 2Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
- 3Department of Dermatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Abstract
Introduction
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.Objective
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.Patients and methods
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.Discussion
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.Trial registration
Chinese Clinical Trial Registry (ChiCTR2500109957) on September 28, 2025.
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BibTeX
@article{zhu2026fecal,
title = {{Fecal microbiota transplantation for the treatment of neurogenic rosacea: protocol of a randomized, blinded, placebo-controlled explorer study.}},
author = {Xia Zhu and Linyan Cheng and Shuxiao Li and Dongjie Guo and WanJun Guo and Xinran Du and Ran Yan and Xinhe Wang and Shaojie Yuan and Moan Chen and Weiming Zhang and Siyu Li and Fulun Li and Lei Zhang},
journal = {Annals of medicine},
year = {2026},
month = oct,
doi = {10.1080/07853890.2026.2735091},
url = {https://europepmc.org/article/MED/42875381},
note = {CC BY},
}
RIS
TY - JOUR
TI - Fecal microbiota transplantation for the treatment of neurogenic rosacea: protocol of a randomized, blinded, placebo-controlled explorer study.
AU - Xia Zhu
AU - Linyan Cheng
AU - Shuxiao Li
AU - Dongjie Guo
AU - WanJun Guo
AU - Xinran Du
AU - Ran Yan
AU - Xinhe Wang
AU - Shaojie Yuan
AU - Moan Chen
AU - Weiming Zhang
AU - Siyu Li
AU - Fulun Li
AU - Lei Zhang
PY - 2026
DA - 2026/10/14
JO - Annals of medicine
DO - 10.1080/07853890.2026.2735091
UR - https://europepmc.org/article/MED/42875381
AB - Introduction 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.Objective 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.Patients and methods 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.Discussion 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.Trial registration Chinese Clinical Trial Registry (ChiCTR2500109957) on September 28, 2025.
SN - 0785-3890
SN - 1365-2060
ER -