Advances in capsule-based fecal microbiota transplantation: clinical applications and innovations

Capsule-based fecal microbiota transplantation (cFMT) has emerged as a vital tool for modulating gut dysbiosis for therapeutic intervention. This noninvasive alternative to traditional FMT avoids procedural invasiveness while offering logistical advantages in terms of storage, administration, and patient compliance. This review evaluates cFMT as a transformative approach across diverse diseases. Notably, cFMT demonstrates robust efficacy in restoring the microbial balance in Clostridioides difficile infection (CDI), inflammatory bowel disease (IBD), and multidrug-resistant infections, with outcomes comparable to those of conventional methods. It also alleviates symptoms and enhances microbiota diversity in small intestinal bacterial overgrowth (SIBO). However, the clinical benefits remain inconsistent for individuals with in irritable bowel syndrome (IBS) and functional constipation (FC), despite alterations in gut microbial diversity. Emerging applications highlight the potential of cFMT metabolic disorders (e.g., obesity and hypertension) via the modulation of gut-derived metabolites and neuropsychiatric conditions (e.g., depression and autism) through gut–brain axis signaling, in addition to chronic kidney disease and hepatic encephalopathy. Challenges such as donor variability, standardization gaps, and transient adverse effects hinder widespread adoption. Further advancements, including targeted colon-release formulations, synthetic microbial consortia, and single-cell delivery systems, could improve precision and scalability. Despite its transformative potential, the clinical adoption of cFMT hinges on rigorous quality control, mechanistic insights, and long-term safety data. In recent years, the United States Food and Drug Administration (FDA) has officially approved the oral microbiome therapy Vowst for marketing. This marked the gradual transition of fecal microbiota transplantation (FMT)-related therapies from clinical research to standardized clinical application, and at the same time, Vowst has become the world’s first oral fecal microbiome therapy approved by the FDA. This review highlights the role of cFMT in microbiota-targeted therapies while advocating for innovation to address current limitations and expand its therapeutic scope.