Abstract
BackgroundThe role of the gut microbiota in Crohn’s disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD.MethodPatients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6).ResultsEight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn’s Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified.ConclusionThe primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797).4Su5uASzbcb9CVTE9bc8YgVideo abstract.
Highlights
The role of the gut microbiota in Crohn’s disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy
We observed taxa associated with maintenance of remission, such as Ruminococcaceae, Coprococcus, and Desulfovibrio genus (Fig. 6b). In this pilot randomized controlled study, we evaluated the effect of a single FMT administered via colonoscopy in patients with colonic or ileo-colonic CD who achieved clinical remission with systemic corticosteroids
We looked for factors on the host side and observed that FMT failure was associated with enrichment in different members of the Gammaproteobacteria class (Proteobacteria phylum) such as Klebsiella, Actinobacillus, and Haemophilus
Summary
The role of the gut microbiota in Crohn’s disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. Its pathogenesis is not fully understood, but it is acknowledged that it is related to an abnormal activation of the gastro-intestinal immune system towards the gut microbiota in genetically susceptible hosts and under the influence of environmental factors [1]. Many studies have shown that the intestinal microbiota in Crohn’s disease patients is abnormal and unbalanced when compared to non-IBD controls, with an increased proportion of potentially pro-inflammatory bacteria such as Escherichia coli and a decrease in antiinflammatory bacteria such as Faecalibacterium prausnitzii [2, 3]. Current therapeutic strategies aim at inhibiting the over-activated immune system and largely ignore the microbial component of disease pathogenesis. Conventional immunosuppressive treatments and biologics used in CD are expensive and associated with potentially severe complications such as infections [6, 7] and cancers, [8] justifying the need for other innovative approaches
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