COMPASSION, EVIDENCE, AND ETHICAL RESPONSIBILITY: THE CASE FOR COMPASSIONATE USE OF FECAL MICROBIOTA TRANSPLANTATION BEYOND RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION

<jats:p>The evolution of Fecal Microbiota Transplantation (FMT) from a "fringe and controversial" procedure to a standardized biological therapy since 1958 represents a significant paradigm shift in medicine. While the FDA and international bodies recognize FMT as a first-line, highly effective, and life-saving treatment for recurrent Clostridioides difficile infection (rCDI), a significant regulatory and ethical gap exists for patients suffering from other conditions thought to be driven by or resulting in intestinal dysbiosis. Evidence from hundreds of clinical trials indicates that FMT holds therapeutic potential for a wide range of disorders, including inflammatory bowel disease (IBD), neurodegenerative diseases such as Parkinson’s and Alzheimer’s, neuropsychiatric conditions like autism and depression, and metabolic syndromes such as obesity and diabetes. However, current regulatory frameworks largely limit clinical use to rCDI, leaving patients with refractory non-rCDI conditions in a "no man’s land" regarding access. This article argues that the ethical principles of beneficence and patient autonomy, combined with increasing safety data, justify the expansion of "compassionate use" or "expanded access" protocols for FMT. By analyzing the tension between the rigorous demands of clinical trials and the urgent needs of suffering patients, we propose an "Accelerated Compassion Model." This model advocates for a regulated pathway that allows access to screened and safe FMT for refractory conditions beyond rCDI, mitigating the risks of the unregulated "do-it-yourself" (DIY) movement while collecting vital real-world data for patients seeking hope for their illnesses.</jats:p>