Randomised, double-blind, placebo-controlled trial of fructo-oligosaccharides in active XXXX .

@entity1 @entity32 @entity688 @entity30 @entity3363
INTRODUCTION: The commensal intestinal microbiota drive the @entity32 associated with @entity30 . However, bacteria such as bifidobacteria and Faecalibacterium prausnitzii appear to be immunoregulatory. In healthy subjects the intestinal microbiota are influenced by prebiotic @entity3363 such as fructo-oligosaccharides (FOS). Preliminary data suggest that FOS increase faecal bifidobacteria, induce immunoregulatory dendritic cell (DC) responses and reduce disease activity in @entity1 with @entity30 . AIMS AND METHODS: To assess the impact of FOS in @entity1 with active @entity30 using an adequately powered randomised double-blind placebo-controlled trial with predefined clinical, microbiological and immunological end points. @entity1 with active @entity30 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 @entity30 Activity Index of >=  70 points) in the intention-to-treat (ITT) population. RESULTS: 103 @entity1 were randomised to receive FOS (n = 54) or placebo (n = 49). More @entity1 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 @entity1 achieving a clinical response between the FOS and placebo groups in the ITT analysis (12 (22%) vs 19 (39%), p = 0.067). @entity1 receiving FOS had reduced proportions of interleukin (IL)-6-positive lamina propria DC and increased DC staining of @entity688 (p < 0.05) but no change in IL-12p40 production. There were no significant differences in the faecal concentration of bifidobacteria and F prausnitzii between the groups at baseline or after the 4-week intervention. CONCLUSION: An adequately powered placebo-controlled trial of FOS showed no clinical benefit in @entity1 with active @entity30 , despite impacting on DC function. ISRCTN50422530.
