New AGA Guideline Supports Fecal Microbiota-Based Therapies for Recurrent C. diff Infections

The American Gastroenterological Association (AGA) has recently released the first comprehensive evidence-based guideline on utilizing fecal microbiota-based therapies for gastrointestinal disease. The guideline primarily recommends fecal microbiota transplant (FMT) for most patients suffering from recurrent Clostridioides difficile (C. diff) infection.

Understanding Fecal Microbiota Transplant

Fecal Microbiota Transplant (FMT), a procedure that involves transferring the fecal bacteria from a healthy donor into a recipient, can significantly reduce the risk of recurrence in patients with recurrent C. diff infection, thus offering hope to patients suffering from this debilitating health issue. Nearly half a million people in the U.S. experience C. diff each year, and around one in six will face a C. diff recurrence within two to eight weeks. FMT therapies have emerged as a safe and effective treatment for such patients.

The AGA Guideline on FMT

The AGA guideline provides specific recommendations for different patient groups, including those with recurrent C. diff at high risk of recurrence following standard-of-care antibiotics and hospitalized patients with severe C. diff infection who show no improvement after standard-of-care antibiotics. The guideline also covers the use of conventional FMT, as well as recently FDA-approved therapies such as fecal microbiota live-jslm (REBYOTA) and fecal microbiota spores live-brpk (VOWST).

Limitations of FMT

However, it is important to note that while FMT has shown promise in treating recurrent C. diff infection, it is not recommended for all gastrointestinal conditions. According to the AGA guideline, FMT therapies are not advised for patients with inflammatory bowel diseases (IBD) or irritable bowel syndrome (IBS). Patients interested in FMT for conditions other than C. diff are encouraged to participate in clinical trials.

Developing the Guideline

The guideline panel, consisting of seven members with clinical expertise, developed recommendations based on evidence gathered from electronic databases and other sources. It identified seven clinically relevant questions about the use of fecal microbiota-based therapies to manage recurrent C. diff infection or conventional FMT for severe to fulminant C. diff, IBD, and IBS. The panel also supplemented randomized controlled trials with observational comparative studies and single-arm observational studies when other evidence was not available.

Implications of the Guideline

The release of this evidence-based guideline represents a significant step in the treatment of recurrent C. diff infection. By providing clear and comprehensive recommendations on the use of FMT, the guideline aims to reduce the suffering of patients with recurrent C. diff infection and guide clinicians in their practice.

The decision to recommend FMT for C. diff infections is significant due to the high prevalence of the condition in the U.S. and the failure of antibiotics to treat it effectively after the third recurrence. Following evidence-based guidelines is essential for the safety and effectiveness of new therapies in clinical practice.