Stool Transplant on Treating Recurrent Clostridium difficile Infection

        A recently published meta analysis in the Journal of Infectious Diseases and Therapy discovered that comparing the efficacy of various treatment regimens for Clostridium difficile infection, fecal microbiota transplant (FMT) after vancomycin therapy was the most effective cure. By reconstituting the normal flora depleted by C. diff infection (CDI), FMT is recommended by the authors as a safe intervention that has the potential to limit the number of severe, recurrent, and prolonged CDI cases. This finding has great potential in influencing the therapeutic guidelines for treating recurrent CDI. 

Process of FMT includes administering stool from a healthy donor to patients who have gastrointestinal disorders through the nose (via nasogastric tube) or mouth (in pill form) or by enema or colonoscopy. Credit: IslandHealth


In the United States, CDI is a prominent healthcare-associated infection caused by the bacterium Clostridium difficile (C. diff). Symptoms can vary from watery diarrhea and abdominal cramping to more severe life-threatening cases that may require hospitalization. Generally, the first-line treatment for CDI is antibiotics, but statistics show that over 20% of people treated with antibiotics will develop recurrent infections. This is because, in addition to killing C. diff, antibiotics disturb the healthy gut microbiota, increase gut dysbiosis, and thus allow C. diff to maintain a stronghold in the gut. As a result, patients remain vulnerable to recurring episodes of CDI following the subsequent treatments with antibiotics. With increasing research demonstrating C. diff resistance towards antibiotics, efforts to develop better therapeutic approaches is critical. 


The authors performed a global systematic literature search of randomized controlled trial (RCT) studies of patients with recurrent C. diff infection. They extracted the details of the study, participants’ information (age and gender), the description of treatments, and the outcome measured. Each study included in the meta-analysis underwent a quality assessment process and the authors concluded that “donor fecal microbiota transplantation showed the highest efficacy in comparison with other therapeutic options.” FMT, also known as stool transplantation, is a well-debated procedure in which stool from a healthy donor is placed into the gut of a patient in order to replenish the “good” microorganisms and prevent C. diff from recurring. While FMT is not a new concept, it is not FDA-approved and current guidelines on FMT treatment are well debated globally. The Infectious Disease Society of America (IDSA) and the American College of Gastroenterology (ACG) recommend FMT for “patients with second, third or subsequent CDI recurrences.” 


The authors concluded that “FMT should be a highly recommended therapy for recurrent C. diff infections.” However, despite their results, the authors mentioned limitations to their meta-analysis study:

  1. The RCTs they included in their analysis did not address bias and some participants may not have been blinded to the intervention. 

  2. The RCTs did not publish a statistical analysis plan, making the symptoms reported subjective. 

  3. The RCTs included a very small sample of patients all of which used different FMT protocols for routes and preparations, antibiotic dosage, and follow-up time.


In addition, according to the FDA, the highly variable nature of human stool and byproducts makes standardization of the treatment unfeasible. Transfering of live microorganisms to recipients with underlying chronic illnesses or immunocompromised patients presents a greater potential risk of transmitting other opportunistic infections. In fact, in March 2020, six patients who received the FMT product for C. diff infection developed infections caused by enteropathogenic E. coli (EPEC) and Shiga toxin-Producing E. coli (STEC).


Other than C. diff infections, FMT has also been studied in the treatment of inflammatory bowel disease (IBD) as a monotherapy or combination therapy. There are no standardized practice guidelines for the use of FMT in IBD to date. In a separate meta-analysis of 4 major RCTs, patients that underwent FMT demonstrated significantly higher clinical remission rates of ulcerative colitis. While the regulations surrounding FMT are currently unclear, FMT is generally accepted to be a safe, well-tolerated, and possibly life-saving procedure for people suffering from C. diff infections. 


What do you think about stool transplants? Would you opt for it knowing it might be the only treatment to cure recurrent C. diff?

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