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<p>The human intestine contains trillions of microorganisms which form an ecosystem that is responsible for regulating gastrointestinal (GI) health. The collection of bacteria, viruses, fungi, and their genes constitutes the microbiome. Dysbiosis, or imbalance of the microbial system, has been linked to diseases such as recurrent <i>Clostridioides difficile</i> infection (rCDI), inflammatory bowel disease (IBD), and colorectal cancer (CRC). Although fecal microbiota transplantation (FMT) has been indicated for safe use in rCDI, reoccurrence remains common. Similarly, in IBD, FMT has shown limited ability to induce clinical remission in patients. Newer strategies for microbial restoration have since emerged, with live biotherapeutic products (LBPs) first defined by the U.S. Food and Drug Administration (FDA) in 2012, and engineered microbial consortia, gaining prominence in the early 2000s. Although FMT remains the main therapy for rCDI, its variable donor compositions and concern for safety have encouraged development of more refined options for microbial restoration. This review will comprehensively examine LBPs such as RBX2660 (Rebyota) and SER-109 (Vowst), in addition to investigational consortia such as VE303, CP101, and MET-2. It also explores their clinical applications, advantages, medical complications, regulatory compliance, and future directions of these microbial therapies.</p>

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Next generation microbiome therapeutics in gastrointestinal disease: from fecal microbiota transplantation to engineered consortia — a narrative review

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月10日

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  • Zaneh Kahook,
  • Mariam Alamgir,
  • Vrinda Mohan,
  • Avinaash Bala Ramasamy,
  • Adwin Haryo Indrawan Sumartono,
  • Anush Manucharyan,
  • Pradeepta Adhikari,
  • Sadhvika Jeripeti,
  • Maneeshaa Mohanarajan,
  • Amy Sherry,
  • Zainab Al Anssari,
  • Alina Sami Khan

摘要

The human intestine contains trillions of microorganisms which form an ecosystem that is responsible for regulating gastrointestinal (GI) health. The collection of bacteria, viruses, fungi, and their genes constitutes the microbiome. Dysbiosis, or imbalance of the microbial system, has been linked to diseases such as recurrent Clostridioides difficile infection (rCDI), inflammatory bowel disease (IBD), and colorectal cancer (CRC). Although fecal microbiota transplantation (FMT) has been indicated for safe use in rCDI, reoccurrence remains common. Similarly, in IBD, FMT has shown limited ability to induce clinical remission in patients. Newer strategies for microbial restoration have since emerged, with live biotherapeutic products (LBPs) first defined by the U.S. Food and Drug Administration (FDA) in 2012, and engineered microbial consortia, gaining prominence in the early 2000s. Although FMT remains the main therapy for rCDI, its variable donor compositions and concern for safety have encouraged development of more refined options for microbial restoration. This review will comprehensively examine LBPs such as RBX2660 (Rebyota) and SER-109 (Vowst), in addition to investigational consortia such as VE303, CP101, and MET-2. It also explores their clinical applications, advantages, medical complications, regulatory compliance, and future directions of these microbial therapies.