Results of a systematic review and meta-analysis published in Microorganisms indicate fecal microbiota transplantation (FMT) is safe and effective for the treatment of pediatric Clostridioides difficile infection (CDI).
Investigators at the University of Nevada searched publication databases through June 2022 for studies that assessed FMT for CDI in the pediatric setting. The primary outcome was the efficacy or clinical success of FMT for the treatment of CDI or recurrent CDI. Pediatric patients were defined as those aged 21 years and younger, and FMT success was defined as resolution of diarrhea symptoms without additional treatment for at least 8 weeks following the procedure. A total of 14 studies were included in this analysis.
The included studies were published between 2014 and 2022 and were of retrospective (n=5), prospective (n=5), and case series (n=4) designs. Most studies (n=13) were conducted in the United States.
The pooled sample size comprised 904 patients. Among studies with demographic data, there were 326 boys or men, 303 girls or women, and the mean patient age was 9.38±2.80 years. The most common comorbidities included inflammatory bowel disease (IBD; n=178), immunodeficiency (n=153), ulcerative colitis (n=83), Crohn disease (n=76), and gastrointestinal disease (n=49).
A total of 13 FMT delivery methods were used in these studies, the most common of which was colonoscopy (49.79%), followed by unspecified lower gastrointestinal tract route (13.48%) and nasogastric tube (11.72%).
The rate of FMT success across each study ranged from 100% (n=7 studies) to 66.67% (n=1 study), with a pooled success rate of 81.86%. Stratified by patient sex, the success rate was higher among girls or women (82.51%) compared with boys or men (78.98%).
In the meta-analysis, the overall clinical success rate was 86% (95% CI, 77%-95%; I2 =70%; P <.001), and girls or women (84%; 95% CI, 78%-90%; I2 =10%; P =.4) had a higher clinical success rate than boys or men (81%; 95% CI, 71%-91%; I2 =40%; P =.1). Of note, the clinical success rate for patients with IBD was 75.33%.
There were 47 adverse events reported among 45 patients and 38 severe adverse events reported among 36 patients, with pooled rates of 2.0% (95% CI, 0.0%-3.0%; I2 =0.0%; P =.1) and 15% (95% CI, 5.0%-25.0%; I2 =54.0%; P =.02), respectively. No deaths were associated with FMT.
The major limitation of this analysis was the lack of randomized controlled trials.
“Despite its efficacy and safety profile, FMT remains a poorly regulated and standardized therapeutic modality,” the investigators concluded.
Tun KM, Hsu M, Batra K, et al. Efficacy and safety of fecal microbiota transplantation in treatment of Clostridioides difficile infection among pediatric patients: a systematic review and meta-analysis. Microorganisms. 2022;10(12):2450. doi:10.3390/microorganisms10122450