Updated March 11, 2025. The FDA issued a safety alert about the transmission of pathogenic E. coli in patients who received fecal microbiota transplant (FMT) from a stool bank company based in the U.S. Two additional patients, who had chronic medical conditions, died. All infected patients received FMT for treatment of C. difficile, which causes colon inflammation.
Four of the six patients were hospitalized. Two patients developed infections caused by enteropathogenic E. coli (EPEC) and four developed infections caused by Shiga toxin-producing E. coli (STEC). The two patients with EPEC infections received FMT product from stool from two different donors, while the four patients with STEC infections received FMT product from stool from a single donor. The patients who died received FMT product from the donor associated with the STEC infections.
OpenBiome, a stool bank company based in Boston, issued a press release in response to the FDA’s alert stating that the infected patients received FMT product that came from three OpenBiome donors. OpenBiome claims that the company immediately implemented changes to its screening program to ensure that FMT material is properly screened moving forward.
Did you contract E. coli from a transplant procedure?
What is FMT?
Fecal microbiota transplant (FMT) is an investigational procedure that involves transferring the stool of a healthy donor to the intestines of a sick person to produce good bacteria and fight infection. The procedure is commonly used for the treatment of C. difficile when patients do not respond to standard treatment options. Researchers have been exploring the use of FMT for conditions ranging from Alzheimer’s to autism.
Understanding the Risk Factors Associated with FMT
The FDA recommends that patients considering FMT to treat C. difficile infections speak to their healthcare providers to understand potential risks. Unfortunately, this is not the first time that FMT patients developed fatal E. coli infections. In June of 2019, two patients died from drug-resistant strains of E. coli transmitted by FMT.
New Study Highlights Risk Factors for Antibiotic Use After Fecal Transplants
A 2025 study published in Open Forum Infectious Diseases sheds new light on the risks associated with antibiotic use after fecal transplant procedures. The study, conducted at six U.S. hospitals, found that patients who underwent FMT for recurrent C. diff infections were more likely to require additional antibiotics within two months. This post-operative health issue could undermine the effectiveness of the treatment.
Researchers identified key risk factors that increased the likelihood of antibiotic use after FMT:
- Weakened immune systems – Patients with compromised immunity were twice as likely to need antibiotics.
- Frequent antibiotic use before FMT – Those who had taken three or more courses of antibiotics before their transplant were three times more likely to need additional antibiotics.
- Previous hospitalization for C. diff – Patients who had been hospitalized for C. diff in the past had double the risk of post-FMT antibiotic use.
These findings are important because antibiotics taken after FMT can disrupt the newly restored gut microbiome, increasing the risk of C. diff recurrence and potentially leading to further health complications. For patients and families navigating C. diff infections and treatment options, understanding these risks can help them make informed decisions about their care. The study highlights the need for healthcare providers to carefully assess each patient, closely monitor recovery, and use antibiotics appropriately to ensure FMT is as effective and safe as possible.
Pritzker Hageman E. coli Legal Team
Our team of E.coli lawyers helps people who develop pathogenic and multi-drug resistant E.coli infections due to medical malpractice. When a medical procedure results in death due to negligence, the family may be able to sue for wrongful death. Recently, our lawyers obtained a $950,000 settlement in a medical malpractice case involving an infection. For a free consultation, please call 1-888-377-8900, text 612-261-0856, or fill out the form below.