This paper describes the protocol for the first clinical trial to explore the effects of fecal microbiota transplantation in the treatment of neurogenic rosacea, a randomized, double-blind, placebo-controlled exploratory trial.
Neurogenic rosacea is identified as a distinct phenotype of rosacea that often responds poorly to conventional therapies.
Gut microbiota dysbiosis is proposed as potentially involved in the pathogenesis of neurogenic rosacea.
The trial is designed as a single-center, randomized, double-blind, placebo-controlled exploratory study enrolling 60 patients with neurogenic rosacea.
The primary outcome measure is the proportion of participants achieving Clinician Erythema Assessment (CEA) success at week 12.
Secondary outcomes include multiple patient-centered and objective measures of disease burden and safety.
This is described as the first clinical trial to explore the effects of fecal microbiota transplantation in the treatment of neurogenic rosacea.
This research describes the design of a clinical trial testing whether fecal microbiota transplantation (FMT) — a procedure that transfers gut bacteria from healthy donors to patients, in this case delivered via capsules — can help people with neurogenic rosacea, a form of rosacea marked by persistent facial redness, flushing, burning, and stinging that typically does not respond well to standard treatments. The rationale is based on growing scientific evidence that an imbalance of gut bacteria may play a role in causing or worsening this condition. Sixty patients will be randomly split into two groups: one receiving FMT capsules and one receiving placebo capsules for three weeks, with follow-up continuing for 12 weeks. The main measure of success will be whether patients show significant improvement in clinician-assessed facial redness. This research suggests that targeting the gut microbiome could be a promising new approach for a skin condition that has historically been difficult to treat. Beyond measuring symptom improvement, the study will also examine changes in gut bacteria composition, blood and stool metabolites, and immune signaling molecules related to nerve and blood vessel function — potentially shedding light on how gut health and skin health are connected. The trial is notable for being described as the first of its kind specifically for neurogenic rosacea. Because this is a study protocol paper rather than a results paper, no clinical outcomes have yet been reported; the findings of the actual trial are pending. The significance of this publication is in establishing the scientific framework and methodology for investigating FMT as a treatment for this difficult-to-treat skin condition, which could open new avenues for patients who have not benefited from conventional therapies.
Zhu X, Cheng L, Li S, Guo D, Guo W, Du X, et al.. (2026). Fecal microbiota transplantation for the treatment of neurogenic rosacea: protocol of a randomized, blinded, placebo-controlled explorer study.. Annals of medicine. https://doi.org/10.1080/07853890.2026.2735091