Fecal Transplant for C Diff in Immunocompromised Patients
Data collection forms were completed for 99 patients who had received FMT at one of the study centers. Of these, 19 were excluded from analysis because they had undergone FMT for treatment of IBD alone (15 patients), did not meet criteria for IC (2 patients), or were lost to follow-up before having their 12-week post-FMT follow-up (2 patients). Eighty patients were included in the final analysis ( Table 1a ). The study population included similar numbers of men (42, 52%) and women (38, 48%). The majority of these patients were adults (75 of 80, 94%) and the mean age of the adults treated was 53 years (range: 20–88 years). Reasons for IC included IBD patients treated with immunosuppressive agents (36, 45%), SOT recipients (19, 24%), and patients IC because of severe or end-stage chronic medical conditions (15, 19%). In addition, there were seven (9%) patients with cancer who were receiving antineoplastic agents concurrently or in the 3 months before FMT, and three (3%) patients had HIV/AIDs. Specific immunosuppressant agents used, indications, and numbers of patients exposed are listed in Table 1b . Recurrent CDI was the most common indication for FMT (44 of 80, 55%). Nine (11%) patients received FMT for refractory CDI and 27 (34%) met criteria for severe or complicated CDI. However, most of these "severe" patients had been treated with a course of anti-CDI therapy and were no longer acutely ill at the time of FMT, which was performed to prevent further recurrence. FMT was conducted as a hospital inpatient in 17 (21.2%) patients and 63 (78.8%) received FMT as outpatients, suggesting that the majority of these patients were clinically stable at the time of FMT. All but one patient had been treated with vancomycin before FMT and 67 (84%) had received multiple, prolonged, or tapering courses of vancomycin. Other therapies used unsuccessfully before FMT included metronidazole (55 patients; 69%), fidaxomicin (23; 29%), rifaximin (13; 16%), and probiotics (30; 38%).
Efficacy. Resolution of CDI occurred in 62 (78%) patients after a single FMT. Twelve patients who either had recurrence or did not respond after one FMT underwent repeat FMT, of whom eight were cured. Thus, overall cure (defined as resolution of CDI after one or more FMTs) within a minimum of 12 weeks was observed in 70 (89%) patients. In the subset of patients with IBD, resolution of CDI occurred in 31 patients (86%) after a single FMT, with an overall cure in 34 (94%).
Safety. SAEs were observed in 12 (15%) patients within 12 weeks post FMT ( Table 2 ). Two deaths occurred. One patient, whose diarrhea ceased after FMT, died 13 days post-FMT secondary to progressive pneumonia, for which she was treated with antibiotics before and after FMT. The other, a SOT recipient with advanced esophageal cancer, cachexia, and ongoing diarrhea from CDI unresponsive to vancomycin and metronidazole, died of respiratory failure 1 day post FMT as a result of a witnessed aspiration at the time of sedation for the colonoscopy used to administer the FMT. There were 10 hospitalizations within 12 weeks of FMT. One patient was hospitalized with self-limited abdominal pain, which occurred after the colonoscopy used to administer FMT and was thus related to FMT. Three hospitalizations were unrelated to FMT and one case of influenza was probably unrelated as the donor did not develop influenza within the follow-up period. Four patients were hospitalized with flares of IBD possibly related to FMT. One catheter line infection requiring hospitalization occurred and was probably unrelated to FMT. There were no infectious complications directly attributable to FMT. Three deaths were reported outside of the 12-week post-FMT period and were not considered as SAEs. All occurred more than 6 months after FMT and were related to chronic progressive illnesses unrelated to CDI.
We observed 12 (15%) patients with AEs ( Table 2 ). Of these, four were related, five were possibly related, and three were unrelated to FMT. Three patients underwent colectomy, although none were for CDI. One patient with ulcerative colitis (UC) had a colectomy less than 1 month post FMT for progressively worsening UC, which had not improved after treatment of CDI. Another patient with UC underwent colectomy 105 days post FMT for indeterminate colitis and a third UC patient underwent colectomy 293 days post FMT for worsening UC. Patients with IBD did not experience a higher incidence of SAEs (11%) or AEs (14%) compared with patients IC because of other conditions (18% SAEs; 16% AEs) P≤0.3224.
Results
Study Patient Characteristics
Data collection forms were completed for 99 patients who had received FMT at one of the study centers. Of these, 19 were excluded from analysis because they had undergone FMT for treatment of IBD alone (15 patients), did not meet criteria for IC (2 patients), or were lost to follow-up before having their 12-week post-FMT follow-up (2 patients). Eighty patients were included in the final analysis ( Table 1a ). The study population included similar numbers of men (42, 52%) and women (38, 48%). The majority of these patients were adults (75 of 80, 94%) and the mean age of the adults treated was 53 years (range: 20–88 years). Reasons for IC included IBD patients treated with immunosuppressive agents (36, 45%), SOT recipients (19, 24%), and patients IC because of severe or end-stage chronic medical conditions (15, 19%). In addition, there were seven (9%) patients with cancer who were receiving antineoplastic agents concurrently or in the 3 months before FMT, and three (3%) patients had HIV/AIDs. Specific immunosuppressant agents used, indications, and numbers of patients exposed are listed in Table 1b . Recurrent CDI was the most common indication for FMT (44 of 80, 55%). Nine (11%) patients received FMT for refractory CDI and 27 (34%) met criteria for severe or complicated CDI. However, most of these "severe" patients had been treated with a course of anti-CDI therapy and were no longer acutely ill at the time of FMT, which was performed to prevent further recurrence. FMT was conducted as a hospital inpatient in 17 (21.2%) patients and 63 (78.8%) received FMT as outpatients, suggesting that the majority of these patients were clinically stable at the time of FMT. All but one patient had been treated with vancomycin before FMT and 67 (84%) had received multiple, prolonged, or tapering courses of vancomycin. Other therapies used unsuccessfully before FMT included metronidazole (55 patients; 69%), fidaxomicin (23; 29%), rifaximin (13; 16%), and probiotics (30; 38%).
Outcomes
Efficacy. Resolution of CDI occurred in 62 (78%) patients after a single FMT. Twelve patients who either had recurrence or did not respond after one FMT underwent repeat FMT, of whom eight were cured. Thus, overall cure (defined as resolution of CDI after one or more FMTs) within a minimum of 12 weeks was observed in 70 (89%) patients. In the subset of patients with IBD, resolution of CDI occurred in 31 patients (86%) after a single FMT, with an overall cure in 34 (94%).
Safety. SAEs were observed in 12 (15%) patients within 12 weeks post FMT ( Table 2 ). Two deaths occurred. One patient, whose diarrhea ceased after FMT, died 13 days post-FMT secondary to progressive pneumonia, for which she was treated with antibiotics before and after FMT. The other, a SOT recipient with advanced esophageal cancer, cachexia, and ongoing diarrhea from CDI unresponsive to vancomycin and metronidazole, died of respiratory failure 1 day post FMT as a result of a witnessed aspiration at the time of sedation for the colonoscopy used to administer the FMT. There were 10 hospitalizations within 12 weeks of FMT. One patient was hospitalized with self-limited abdominal pain, which occurred after the colonoscopy used to administer FMT and was thus related to FMT. Three hospitalizations were unrelated to FMT and one case of influenza was probably unrelated as the donor did not develop influenza within the follow-up period. Four patients were hospitalized with flares of IBD possibly related to FMT. One catheter line infection requiring hospitalization occurred and was probably unrelated to FMT. There were no infectious complications directly attributable to FMT. Three deaths were reported outside of the 12-week post-FMT period and were not considered as SAEs. All occurred more than 6 months after FMT and were related to chronic progressive illnesses unrelated to CDI.
We observed 12 (15%) patients with AEs ( Table 2 ). Of these, four were related, five were possibly related, and three were unrelated to FMT. Three patients underwent colectomy, although none were for CDI. One patient with ulcerative colitis (UC) had a colectomy less than 1 month post FMT for progressively worsening UC, which had not improved after treatment of CDI. Another patient with UC underwent colectomy 105 days post FMT for indeterminate colitis and a third UC patient underwent colectomy 293 days post FMT for worsening UC. Patients with IBD did not experience a higher incidence of SAEs (11%) or AEs (14%) compared with patients IC because of other conditions (18% SAEs; 16% AEs) P≤0.3224.
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