Revisiting the Guidelines for Fecal Microbiota-Based Therapies

Revisiting the Guidelines for Fecal Microbiota-Based Therapies

The American Gastroenterological Association (AGA) has recently endorsed the use of fecal microbiota-based therapies for recurrent Clostridioides difficile infections (CDIs). The guideline recommendations suggest that immunocompetent adults with recurrent CDIs should receive such therapies after completing treatment with standard-of-care antibiotics. On the other hand, mildly or moderately immunocompromised adults with recurrent CDIs are advised to undergo conventional fecal microbiota transplant. The AGA panel also emphasized the importance of a multidisciplinary approach for adults hospitalized with severe or fulminant CDI, involving critical care, surgery, gastroenterology, and infectious disease teams.

However, the AGA guidelines do not support the use of fecal microbiota-based therapies for inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) at this time. The guideline panel cautioned against treating IBD, including Crohn’s disease, ulcerative colitis, and pouchitis, as well as IBS, due to the lack of sufficient evidence. Clinicians are advised to refer to these guidelines and explain to patients that the use of such therapies for IBD or IBS is not yet recommended.

One of the major concerns highlighted by the guideline authors is the process of selecting stool donors for fecal microbiota-based therapies. They pointed out that paid donors may have a financial incentive to hide information about their health or risky behaviors, similar to the concerns associated with paid blood donation. The screening process for stool donors is not transparent, and there are uncertainties about how it will adapt to emerging infections. These concerns raise questions about the safety and efficacy of fecal microbiota-based products.

While international organizations have integrated recommendations for fecal microbiota-based therapies into CDI treatment guidelines, newer products have not been included in these guidelines. The AGA guidelines are more comprehensive, covering all potential indications for fecal microbiota transplant, even outside the realm of CDI. It is important to note that fecal microbiota transplant is contraindicated in certain patient populations, such as those with bowel perforation or obstruction, severe immunocompromisation, or specific underlying conditions.

Despite the publication of the new guidelines, the AGA emphasizes that all recommendations are conditional and based on low- to very-low-certainty evidence. This underscores the need for further research and clinical studies to establish the safety and efficacy of fecal microbiota-based therapies for different conditions. The guidelines serve as a framework for clinicians to make informed decisions about the appropriate use of these therapies in clinical practice.

The AGA’s endorsement of fecal microbiota-based therapies for recurrent CDIs brings new insights into the management of these infections. However, the restrictions on the use of these therapies for IBD and IBS highlight the gaps in current evidence. Addressing concerns about the stool donor process and expanding guidelines to cover additional indications are critical steps in ensuring the safe and effective use of fecal microbiota-based therapies. Despite the limitations of existing evidence, the AGA guidelines provide valuable guidance for clinicians in navigating the complexities of utilizing these innovative treatment modalities.


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