Fecal microbiota transplantation (FMT) is as effective as glucocorticoids in inducing clinical and endoscopic remission of mild to moderate ulcerative colitis (UC), according to study findings published in the Journal of Translational Medicine.
Researchers conducted a single-center, prospective cohort study (ClinicalTrials.gov Identifier: NCT02435160) of 122 patients diagnosed with mild to moderate UC. Between September 2015 and September 2021, researchers enrolled patients from the Shanghai General Hospital in China. Sixty-two patients received treatment with FMT for 3 days, and 60 patients received treatment with glucocorticoids. By the end of the study, 6 patients in the FMT group withdrew from therapy or experienced treatment failure, and 4 experienced treatment failure in the glucocorticoid group.
After 12 weeks, the remaining patients underwent a follow-up assessment, including a clinical evaluation, blood tests, and an endoscopy to determine if the UC was in remission. Researchers determined endoscopic UC remission based on total Mayo scores and endoscopic Mayo scores.
Routine blood work analyzed serum levels of inflammatory mediators, including tumor necrosis factor alpha (TNF-α), interferon gamma (IFN-ϒ), and interleukin (IL)-1β, IL-4, IL-5, IL-6, IL-10 IL-8, IL-12p70, IL-13, IL-17A and IL-23. The researchers also gathered information regarding adverse events to assess safety of the interventions.
The primary outcome was clinical and endoscopic remission at 12 weeks.
In the FMT group, 54.8% of patients achieved clinical and endoscopic UC remission. In the glucocorticoid group, 48.3% of patients achieved clinical and endoscopic UC remission. Researchers observed no significant difference between the groups in the interventions inducing clinical and endoscopic UC remission (risk ratio [RR], 1.13; 95% CI, 0.8-1.6; P =.59).
The erythrocyte sedimentation rate (ESR) significantly decreased in the FMT group (P =.008) and the glucocorticoid group (P =.023), but no other complete blood count values changed significantly.
Researchers subdivided the FMT group into responders and nonresponders. In the FMT responder subgroup, serum levels of TNF-α and IL-6 significantly decreased (P <.05, respectively), while the IL-10 levels significantly decreased in the FMT nonresponder subgroup (P <.05).
Patients in the glucocorticoid group experienced more adverse events than those in the FMT group (58.3% vs. 22.6%; P <.001). Two serious adverse events occurred in the glucocorticoid group, including worsening UC and cytomegalovirus infection requiring colectomies.
“FMT was as effective as GCs [glucocorticoids] to be a remission induction therapy with fewer adverse events,” the study authors wrote.
Study limitations include a need to examine the underlying mechanism of action of FMT and causative mechanisms prompting UC remission.
Huang C, Huang Z, Ding L, et al. Fecal microbiota transplantation versus glucocorticoids for the induction of remission in mild to moderate ulcerative colitis. J Transl Med. 2022;20:354. doi:10.1186/s12967-022-03569-3