Randomised, double-blind, placebo-controlled trial of fructo-oligosaccharides in active Crohn's disease

Jane L. Benjamin, Charlotte R. H. Hedin, Andreas Koutsoumpas, Siew C. Ng, Neil E. McCarthy, Ailsa L. Hart, Michael A. Kamm, Jeremy D. Sanderson, Stella C. Knight, Alastair Forbes, Andrew J. Stagg, Kevin Whelan, James O. Lindsay

Research output: Contribution to journalArticlepeer-review

299 Citations (Scopus)

Abstract

Introduction The commensal intestinal microbiota drive the inflammation associated with Crohn's disease. However, bacteria such as bifidobacteria and Faecalibacterium prausnitzii appear to be immunoregulatory. In healthy subjects the intestinal microbiota are influenced by prebiotic carbohydrates such as fructo-oligosaccharides (FOS). Preliminary data suggest that FOS increase faecal bifidobacteria, induce immunoregulatory dendritic cell (DC) responses and reduce disease activity in patients with Crohn's disease. Aims and methods To assess the impact of FOS in patients with active Crohn's disease using an adequately powered randomised double-blind placebo-controlled trial with predefined clinical, microbiological and immunological end points. Patients with active Crohn's disease were randomised to 15 g/day FOS or non-prebiotic placebo for 4 weeks. The primary end point was clinical response at week 4 (fall in Crohn's Disease Activity Index of >= 70 points) in the intention-to-treat (ITT) population. Results 103 patients were randomised to receive FOS (n=54) or placebo (n=49). More patients receiving FOS (14 (26%) vs 4 (8%); p=0.018) withdrew before the 4-week end point. There was no significant difference in the number of patients achieving a clinical response between the FOS and placebo groups in the ITT analysis (12 (22%) vs 19 (39%), p=0.067). Patients receiving FOS had reduced proportions of interleukin (IL)-6-positive lamina propria DC and increased DC staining of IL-10 (p
Original languageEnglish
Pages (from-to)923 - 929
Number of pages7
JournalGut
Volume60
Issue number7
DOIs
Publication statusPublished - Jul 2011

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