Fecal transplantation in patients with moderately to severely chronic active ulcerative colitis (UC)

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Abstract

Aims: A diminished biodiversity of the intestinal flora has been reported in patients with IBD. Restoration of a normal flora is being discussed as an alternative treatment approach. Methods: We assessed safety and efficacy of fecal transplantation (FT) in moderately to severely, chronic active patients with UC (n=5, f/m: 2/3, median Mayo score: 11) refractory to standard therapy. Immunosuppressive therapy was stopped prior FT. Fecal donors were healthy adults with normal bowel function who were screened for enteric pathogens and serologically for viral diseases. Donor stool was diluted in saline and administered via nasojejunal tube and enema. Adverse events and blood tests were regularly obtained during a follow-up of 12 weeks. H2-glucose breath test was performed to exclude bacterial overgrowth at wk 4 and wk 12. Clinical activity was assessed according to Mayo Score. Results: Patients completed an antibiotic (n=5) and probiotic (n=4) therapy for 5 to 10 days and a single bowel lavage before FT. FT was performed daily for 3 days (n=4). In one patient there was a gap of 5 weeks between the first and the second FT due to fever >39°C and a >8-fold increase of C-reactive protein (CRP) after first FT. Altogether, median 23.8g (range: 16.7g-25g) and 20g (range: 6g-21.7g) stool was administered via nasojejunal tube and enema, respectively. All of the patients reported on worsening of diarrhoea and fever during FT. Additionally, a temporary increase of CRP was observed. In patients (n=2), who had a temperature >38°C blood cultures were taken, but no bacterial pathogen was detectable. Additionally, flatulance (n=1) and vomiting (n=1) were reported. In the follow-up period common cold (n=3), itchiness (n=1), erythema (n=1), paraesthesia on the hip (n=1), collapse (n=1), and blisters on the tongue (n=1) were reported. No serious adverse event occurred. Bacterial overgrowth was not detectable in any patient. In 2 patients a further deterioration of UC was observed. Although the general well-being improved from poor to very well at week 12 in the other 3 patients, the median total Mayo score improved only from 11 to 9. In one patient there was an improvement of the Mayo endoscopic subscore from 3 to 2. Conclusion: In our experience FT might be safe but activates a temporary systemic immune response. Our preliminary data are less impressive with regard to efficacy after a minimum follow-up of 12 weeks.