https://gastroenterology.acponline.org/archives/2025/08/22/1.htm

FMT appears safe, effective for recurrent C. diff in immunocompromised patients

Patients with mild to moderate immunocompromise and recurrent Clostridioides difficile infection had similar outcomes to immunocompetent patients after fecal microbiota transplantation (FMT), according to a systematic review and meta-analysis.


Fecal microbiota transplantation (FMT) for recurrent Clostridioides difficile infection is a safe and effective option for patients with mild to moderate immunocompromise, a systematic review and meta-analysis found.

Researchers examined studies published until Dec. 16, 2024, that focused on FMT for recurrent C. diff in immunocompromised patients, including those on immunosuppressants, transplant recipients, those undergoing chemotherapy, and those with advanced HIV infection. Primary outcomes included resolution of C. diff infection after single and multiple treatments, recurrence, and adverse events. The results were published Aug. 2 by Clinical Gastroenterology and Hepatology.

Thirty-one cohort studies and 13 case series involving 3,476 patients (mean age, 49.17 years; 42.8% female) were included in the analysis. Median follow-up was six months (interquartile range, three to 12 months) in the 34 studies that reported follow-up duration. Among 1,208 patients with immunocompromise, 393 were taking immunosuppressive medications, 219 were solid organ transplant recipients, 101 were patients with cancer receiving chemotherapy, 29 were recipients of hematopoietic stem-cell transplants, 18 had primary immunodeficiency, and 11 had advanced HIV infection. Colonoscopy, used in 12 studies, was the most common FMT route, followed by upper GI routes, capsules, and rectal retention enemas.

The clinical resolution rate was 75.3% (95% CI, 71.7% to 78.6%) after a single FMT and increased to 87.4% (95% CI, 84.8% to 89.6%) with consecutive treatments. The recurrence rate was 23.9% (95% CI, 19.2% to 29.4%), while the rate of serious adverse events (life-threatening events, hospitalizations, or significant medical occurrences) was 10.1% (95% CI, 6.7% to 14.8%).

Donor screening procedures and FMT protocols varied across studies, none of which were randomized controlled trials, the authors noted. They concluded that FMT is an effective treatment for preventing recurrent C. diff and resolving symptoms in patients with mild to moderate immunocompromise.

“Although adverse events are notable, the [severe adverse event] incidence … remains comparable to general FMT-treated populations,” they wrote. “Therefore, FMT should be considered based on individualized risk-benefit assessment, factoring in the degree of immunosuppression and clinical profile.” The authors called for future prospective controlled studies with standardized designs and further exploration of regulated, standardized live biotherapeutic products as potential FMT alternatives, “particularly in severely immunocompromised patients where conventional FMT remains contraindicated and safety data are currently limited.”