Fecal microbiota transplantation for the treatment of neurogenic rosacea: protocol of a randomized, blinded, placebo-controlled explorer study.
Xia Zhu, Linyan Cheng, Shuxiao Li et al.
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In 30 seconds
This publication describes the protocol for a single-center, randomized, double-blind, placebo-controlled exploratory trial of fecal microbiota transplantation (FMT) in patients with neurogenic rosacea, a phenotype often poorly responsive to conventional therapies. Sixty participants are planned to receive FMT or placebo capsules for 3 consecutive weeks, with follow-up for 12 weeks. The primary outcome is the proportion achieving clinical erythema assessment (CEA) success at week 12, defined as a score of 0 or 1 or a reduction of ≥2 grades from baseline. No efficacy or safety results are reported.
Key findings
- The protocol plans to randomize 60 patients 1:1 to FMT capsules or placebo.
- Treatment is planned for 3 consecutive weeks, followed by 12 weeks of follow-up.
- The primary endpoint is CEA success at week 12, defined as a score of 0 or 1 or a reduction of ≥2 grades from baseline.
- Secondary assessments include symptoms, quality of life, psychological status, erythema, safety, and exploratory microbiome and metabolomic measures.
Why it matters
Neurogenic rosacea can respond poorly to conventional therapies, and the protocol tests whether targeting gut microbial composition may offer a therapeutic approach. Its blinded, placebo-controlled design and assessment of clinical outcomes, safety, and potential mechanisms could help clarify whether FMT warrants further study. The abstract provides no trial results, so efficacy and safety remain undetermined.
What to keep in mind
This is a single-center exploratory trial protocol; the abstract reports planned methods, not clinical results.