# P-161. Real-world Outcomes of Patients Receiving Fecal Microbiota Transplant for Recurrent C. Difficile Infection

## TL;DR

This study examines real-world outcomes of fecal microbiota transplant for recurrent C. difficile infection, finding that older patients and those on immunosuppressants are more likely to experience recurrence.

## Contribution

The study identifies patient-specific risk factors for FMT failure in real-world settings, extending prior clinical trial findings.

## Key findings

- The 60-day recurrence rate after FMT was 20%, similar to clinical trial results.
- Older age and immunosuppressant use were independently associated with higher recurrence risk.
- 24% of patients required more than one FMT due to recurrence.

## Abstract

Up to 30% of patients with Clostridioides difficile infection (CDI) recur after initial treatment. Fecal microbiota transplantation (FMT) restores gut microbiota and was highly effective in reducing recurrence of CDI (rCDI) in clinical trials, though real-world outcomes vary based on patient factors. This study evaluated outcomes of FMT, including rCDI and predictors of early FMT failure.Table 1.Patient demographics and primary infection characteristicsBaseline demographics and number of reoccurrences prior to FMT.Table 2.Recurrences, subsequent antibiotic use, and outcomes after FMTClinical outcomes following FMT, including recurrence rates, post-procedure events, and need for repeat transplantation.

Patient demographics and primary infection characteristics

Baseline demographics and number of reoccurrences prior to FMT.

Recurrences, subsequent antibiotic use, and outcomes after FMT

Clinical outcomes following FMT, including recurrence rates, post-procedure events, and need for repeat transplantation.

Retrospective cohort study of adult outpatients who received FMT via donor stool enema prepared in accordance with institutional protocols for rCDI between 2018 and 2023 at Henry Ford Hospital. Patients with incomplete data were excluded. Collected data included demographics, comorbidities, prior CDI (pCDI) and rCDI, and subsequent antibiotic (abx) use. A multistep algorithm with enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase antigen followed by NAAT for discordant EIA results is utilized in our institution. Recurrence was defined as a positive stool test and treatment of CDI. The primary outcome was rCDI within 60 days post-FMT. Univariate logistic regression was conducted using R version 4.2.2 to screen potential predictors of recurrence within 60 days. Variables meeting a significance threshold of p ≤ 0.2 were subsequently entered into a multivariate logistic regression model to identify independent risk factors.Table 3.Univariate and multivariate analysis depicting the risk factors for CDI recurrence within 60 days after FMTMultivariable analysis of factors associated with 60-day CDI recurrence following FMT. Older age and use of immunosuppressant medications were independently associated with increased odds of recurrence.

Univariate and multivariate analysis depicting the risk factors for CDI recurrence within 60 days after FMT

Multivariable analysis of factors associated with 60-day CDI recurrence following FMT. Older age and use of immunosuppressant medications were independently associated with increased odds of recurrence.

Of 148 patients who received FMT, 108 were included with median age 67 years. Most were white (78.5%) females (67.6%) with >2 episodes of pCDI (65.7%) [Table 1]. Patients were rarely exposed to abx within 60 days of FMT. In most FMT patients, rCDI occurred within 12 months; of these, 29 (20%) within 60 days (Table 2). Age (p< 0.05) and receipt of immunosuppressant medications (p< 0.05) were associated with 60-day rCDI but not abx exposure or pCDI [Table 3]. Almost a quarter (24%) of patients received more than one FMT.

In this large study of patients receiving FMT for rCDI, the 60-days recurrence rate was similar to that observed in earlier clinical trials, with older patients and those receiving immunosuppressant medications more likely to fail.

Mayur Ramesh, MD, Citius Pharmaceuticals, Inc.: Grant/Research Support