Randomised, double-blind, placebo-controlled trial of fructo-oligosaccharides in active Crohn's disease - PubMed (original) (raw)
Randomized Controlled Trial
doi: 10.1136/gut.2010.232025. Epub 2011 Jan 24.
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
Affiliations
- PMID: 21262918
- DOI: 10.1136/gut.2010.232025
Randomized Controlled Trial
Randomised, double-blind, placebo-controlled trial of fructo-oligosaccharides in active Crohn's disease
Jane L Benjamin et al. Gut. 2011 Jul.
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 < 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 patients with active Crohn's disease, despite impacting on DC function. ISRCTN50422530.
Comment in
- Prebiotic carbohydrates: not sweet yet for Crohn's disease?
Marteau P. Marteau P. Gut. 2011 Jul;60(7):882-3. doi: 10.1136/gut.2010.234369. Epub 2011 Mar 24. Gut. 2011. PMID: 21436225 No abstract available. - Fructo-oligosaccharides as therapeutics for active Crohn's disease: adequate power and no effect.
Valcheva R, Dieleman LA. Valcheva R, et al. Inflamm Bowel Dis. 2012 Feb;18(2):391-2. doi: 10.1002/ibd.21760. Epub 2011 May 25. Inflamm Bowel Dis. 2012. PMID: 21618354 No abstract available. - Effect of oligofructose-enriched inulin (OF-IN) on bacterial composition and disease activity of patients with Crohn's disease: results from a double-blinded randomised controlled trial.
Joossens M, De Preter V, Ballet V, Verbeke K, Rutgeerts P, Vermeire S. Joossens M, et al. Gut. 2012 Jun;61(6):958. doi: 10.1136/gutjnl-2011-300413. Epub 2011 Jul 11. Gut. 2012. PMID: 21749983 No abstract available.
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