Clear Evidence, No Trials - Mycobiome IBS and Antifungals

Upon literature review, no randomized controlled trial of antifungal therapy versus placebo has been published in irritable bowel syndrome (IBS) patients stratified by mycobiome profile, despite rat-model causation established in 2017 (Botschuijver et al., Gastroenterology) and human strain-level phenotypic characterization published in 2021 (Sciavilla et al., Applied Microbiology and Biotechnology). The foundational causation paper has accumulated more than 240 citations as of April 2026. Observational confirmation has accumulated across multiple independent human cohorts. The proposed intervention, a generic oral fluconazole at standard dosing, averages \$15 to \$35 per month at US retail pharmacies. The branded IBS drugs approved between 2000 and 2019 cost between \$300 and \$2,650 per month. The trial has not been run. This paper, the first in the Clear Evidence, No Trial series from the Redacted Science Research Initiative, documents what the evidence shows, what the trial should look like, and why it has not been conducted. The paper makes no claim requiring acceptance of any particular interpretive framework; the documented absence stands on its own terms. A companion pre-registered trial protocol is deposited separately. https://www.jimcraddock.com/