Clinical Landscape of Microbiome Modulators in Gynecological Tumor Treatment: From Pre-Clinical to Clinical Trials.

Intestinal microbiota dysbiosis is linked to gynecological tumors (endometrial, ovarian, cervical cancers), and microbiome modulators show therapeutic potential by regulating gut microbiota. This Perspective analyzes the field from pre-clinical to clinical stages. Pre-clinically, a Web of Science bibliometric analysis (2010-2025, 114 articles, 86 reviews) revealed focus on "epithelial ovarian cancer," "estrogen," and "mechanism," with key studies by Baker et al. (2017, gut microbiota-estrogen-endometrial cancer link) and Kopustinskiene et al. (2020, flavonoids' anti-tumor effect via gut flora). Clinically, 4 INFORMA-database trials (2 closed, 1 completed, 1 planning) targeted ovarian/endometrial cancer (no cervical cancer trials), using live microorganisms/faecal modulators mainly for immuno-oncology therapy; bacteriophages (e.g., M13) also emerged as potential modulators. Challenges include unclear optimal combination therapies, lack of cervical cancer trials, and limited modulator types. This analysis offers a field overview and future research directions. The intestinal microbiota constitutes a complex ecological community that influences the normal physiological and pathological processes of distal organs through its metabolic activities. Previous research has demonstrated that dysbiosis of the intestinal microbiota can contribute to the development of endometrial cancer, ovarian cancer, and cervical cancer 1-3. Microbiome modulators enhance host health by regulating the intestinal microbiota and hold potential as therapeutic agents for gynecological tumors 4. Consequently, it is imperative to analyze the landscape of clinical trials investigating the efficacy of microbiome modulators in the treatment of gynecological tumors.