Abstract
Introduction: Fecal Microbiota transplantation (FMT) is recommended for treatment of recurrent Clostridioides difficile infection (CDI) with reported success rates of 80-90%. There are limited data on factors contributing FMT failure, particularly in the outpatient setting. Our objective was to describe FMT failure rates within one year and to evaluate factors associated with FMT failure. Methods: We conducted a retrospective cohort study of consecutive patients who had outpatient FMT at Baystate Medical Center, Springfield, MA from 12/14 through 9/18. We collected patient data including demographics, CDI related factors, comorbid conditions, medications and FMT route. FMT failure was defined as non-response or recurrence of diarrhea, associated with positive stool C. diff toxin or PCR. IRB approval was obtained. Unadjusted relative risk (RR) and 95% confidence intervals for factors associated with FMT failure were estimated using log-binomial regression. Due to low power, we present possible associations with p-values < 0.2. Results: 92 patients were included with a mean age of 64y. CDI severity (per IDSA guidelines) was mild/moderate in 73% and severe or fulminant in 27%. 69% of patients had been previously hospitalized for CDI and the most common FMT indication was recurrent CDI in 76%. FMT failure occurred in 25 of 92 (27%) of which half occurred within 21 days. Factors associated with FMT failure were immunosuppression (RR=2.90); current or previous malignancy (RR=2.50); prior hospitalizations (RR=2.42); and receipt of non-CDI antibiotics within 6 months of FMT (RR=2.80). None of the following factors were associated with risk of FMT failure: age, indication, CDI severity, history of colectomy, diabetes, prior radiation, history of appendectomy, probiotics prior to FMT, H2 antagonists or PPIs, ICU admission, inflammatory bowel disease, or route of FMT delivery (oral, NGT, colonoscopy). (Table) Conclusion: We have identified four factors associated with FMT failure for outpatients with recurrent CDI: immunosuppression, current or previous malignancy, prior CDI hospitalizations and non-CDI antibiotics within 6 months prior to FMT. Knowledge of the above factors may help inform treatment options for patients with recurrent or refractory CDI. Table 1. - Univariable analysis of associations between factors associated with FMT failure within one year Overall FMT FailureNo FMT FailureYes p- value Relative Risk N=92 N=67 N=25 (95% CI) Age at transplant (yrs) 63.9 65.1 60.7 0.319 0.92 (0.77 to 1.10) Male n=20 (21.7%) Female n=72 (78.3%) FMT Indication Recurrent CDI 70 (76.1%) 54 (77.1%) 16 (22.9%) 0.062 n/a Severe CDI 3 (3.3%) 3 (100.0%) 0 (0.0%) Fulminant Colitis 2 (2.2%) 2 (100.0%) 0 (0.0%) Recurrent and Severe CDI 17 (18.5%) 8 (47.1%) 9 (52.9%) CDI Severity Mild/Moderate 67 (72.8%) 51 (76.1%) 16 (23.9%) 0.415 Referent Severe 15 (16.3%) 10 (66.7%) 5 (33.3%) 1.40 (0.61 to 3.21) Fulminant Colitis 10 (10.9%) 6 (60.0%) 4 (40.0%) 1.67 (0.70 to 4.00) Prior Hospitalization Due to C. Diff No 29 (31.5%) 25 (86.2%) 4 (13.8%) 0.076 Referent Yes 63 (68.5%) 42 (66.7%) 21 (33.3%) 2.42 (0.91 to 6.40) Immunosuppression No 57 (62.0%) 48 (84.2%) 9 (15.8%) 0.003 Referent Yes 35 (38.0%) 19 (54.3%) 16 (45.7%) 2.90 (1.44 to 5.83) Current or Previous Malignancy No 70 (76.1%) 56 (80.0%) 14 (20.0%) Referent Yes 22 (23.9%) 11 (50.0%) 11 (50.0%) 0.012 2.50 (1.33 to 4.68) Antibiotics (6 mos. prior to cdiff; not treating c.diff.) No 32 (34.8%) 28 (87.5%) 4 (12.5%) 0.027 Referent Yes 60 (65.2%) 39 (65.0%) 21 (35.0%) 2.80 (1.05 to 7.46)
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