The American Gastroenterological Association (AGA) recommends fecal microbiota-based therapies, including conventional transplants and FDA-approved treatments for adults with recurrent or severe Clostridioides difficile infection (CDI), inflammatory bowel diseases, and irritable bowel syndrome. Fecal microbiota-based treatments are an effective option to prevent recurrent C difficile infections in certain patients. For select adults hospitalized with severe or fulminant infections that do not respond to standard antibiotics, conventional fecal microbiota transplantation serves as an adjunct therapy.
The guideline panel issued 7 recommendations. For immunocompetent adults experiencing recurrent C difficile infection, the AGA recommends the selective use of fecal microbiota-based therapies after completing standard antibiotics to prevent recurrence. In adults with mild or moderate immunocompromise and recurrent infection, the AGA advises the selective use of conventional fecal microbiota transplant. However, for severely immunocompromised adults, the AGA recommends against any fecal microbiota-based therapies to prevent recurrent C difficile. For adults in the hospital with severe or fulminant C difficile not responding to standard antibiotics, the AGA advises the selective use of conventional fecal microbiota transplant. The AGA advises against conventional fecal microbiota transplant for treating inflammatory bowel diseases or irritable bowel syndrome, unless within a clinical trial setting.
“We identified 11 randomized controlled trials, including 1172 patients with nonsevere, nonfulminant recurrent CDI, that compared fecal microbiota–based therapies with standard of care, placebo, autologous FMT, or rectal bacteriotherapy,” according to the investigators. “The panel agreed that the selection of only 12 bacterial strains was not fecal microbiota–based therapy and could be classified with the placebo interventions for this analysis. Most trials included adults with a history of multiply recurrent, nonsevere, nonfulminant CDI. The diagnosis of CDI was based on toxin assays and/or nucleic acid amplification tests.”1
3 Key Takeaways
- Fecal microbiota-based therapies, including conventional transplants and FDA-approved treatments, have been recommended by the AGA for adults with recurrent or severe C difficile.
- The guidelines suggest a selective application of these therapies based on the patient's immunocompetence level and the severity of the infection.
- Despite the positive outcomes, the AGA calls for more research to fully understand the impact of fecal microbiota-based therapies on quality of life and to optimize patient outcomes.
Fecal microbiota-based therapies significantly increase the likelihood of preventing recurrent C difficile infection, with an overall 74.2% success rate compared to 51.7% in controls, translating into 305 more per 1000 patients benefiting from these therapies. The guideline was crafted utilizing the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to prioritize clinical inquiries, pinpoint outcomes centered on the patient, and perform a synthesis of evidence. Utilizing the Evidence-to-Decision framework, the guideline panel formulated recommendations for employing fecal microbiota-based therapies in the outlined gastrointestinal conditions and offered considerations for their implementation in clinical settings.
“CDI continues to be recognized by the CDC as a major health threat, with 462,000 CDI cases in the United States annually. The panel made a conditional recommendation for the use of fecal microbiota–based therapies in immunocompetent adults with recurrent CDI,” according to investigators. “Conventional FMT for prevention of recurrent CDI is available via nonprofit stool banks and within select academic centers. FDA-approved fecal microbiota live-jslm, and fecal microbiota spores live-brpk are commercially available products. Health care systems and policymakers should consider how material acquisition will affect cost and access.”1
Despite their effectiveness in recurrence prevention, the impact on quality-of-life improvement is minimal, with changes not reaching the minimal clinically important difference. Additionally, there's no significant difference in serious adverse events between treated patients and controls, indicating a safe profile for these therapies. However, the limited data on quality of life and the variable effectiveness between different therapy types highlight the need for further research to optimize patient outcomes.
In summary, the AGA guidelines highlight the fecal microbiota-based therapies in managing certain gastrointestinal conditions, despite the need for further research to fully understand their impact on quality of life.
Reference
1. Peery A, Kelly C, Kao D, Imdad, Altayar O, et, al. AGA Clinical Practice Guideline on Fecal Microbiota–Based Therapies for Select Gastrointestinal Diseases. Gastroenterology. Published March 2024. Accessed February 23, 2024. doi: https://doi.org/10.1053/j.gastro.2024.01.008
