Title: Fecal Microbiota Transplantation in Gastrointestinal, Hepatic, and Immunotherapy Settings: A Critical Narrative Review of Therapeutic Promise, Mechanistic Mysteries, Safety Concerns, and Regulatory Quagmires

Authors: Dr Keemaya Gurudutt Joglekar, M.B.B.S., Dr. Amit Ajit Desai, M.S., M.R.C.S, FIAGES

 DOI: https://dx.doi.org/10.18535/jmscr/v13i09.01

Abstract

 

Fecal microbiota transplantation (FMT) has exploded from a remarkable salvage therapy for recurrent Clostridioides difficile infection (rCDI) into a seemingly universal microbiome “reset” with applications spanning inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), liver pathology, hematopoietic stem cell transplantation (HSCT), and cancer immunotherapy (Vaughn et al., 2020; Benech & Sokol, 2023). Yet, beneath the optimism lies a striking paradox: while FMT’s efficacy in rCDI is nearly irrefutable, outcomes in other conditions are inconsistent, poorly understood, and marred by methodological chaos (Porcari et al., 2023). This narrative review critically examines clinical trial results, explores the still-elusive mechanistic underpinnings involving microbial diversity restoration, immunomodulation, and metabolites like short-chain fatty acids (SCFAs), and exposes the fragmented regulatory environment (El-Salhy et al., 2023; Lo et al., 2024). Challenges such as donor variability, recipient microbiome complexity, ethical dilemmas, and insufficient long-term safety data fuel skepticism (Benech & Sokol, 2023). The path forward demands not just enthusiasm but rigorous, standardized clinical trials and harmonized regulatory frameworks that acknowledge the complexities of microbial therapeutics—otherwise, FMT risks becoming yet another overhyped treatment without clear clinical integration (Porcari et al., 2023; Vaughn et al., 2020).

Keywords- Fecal microbiota, Inflammatory bowel disease.

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