Randomised, double-blind, placebo-controlled trial of fructo-oligosaccharides in active Crohn's disease
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 .
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A subsequent randomised placebo-controlled trial of fructo-oligosaccharide in Crohn's disease did not support any clinical benefit.
“a subsequent randomised placebo-controlled trial of fructo-oligosaccharide did not support any clinical benefit.80”
From The gut microbiota and host health: a new clinical frontier (2016) · cites this paper as [80]
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- Authors
- Benjamin, J. L., Hedin, C. R. H., Koutsoumpas, A., Ng, S. C., McCarthy, N. E., Hart, A. L., Kamm, M. A., Sanderson, J. D., Knight, S. C., Forbes, A., Stagg, A. J., Whelan, K., & Lindsay, J. O.
- Affiliations
- King's College London (GB)
- Chinese University of Hong Kong (HK)
- Queen Mary University of London (GB)
- The University of Melbourne (AU)
- Imperial College London (GB)
- University College London (GB)
- ORCID
- Venue
- Gut
- Publisher
- BMJ
- Published
- 2011-01-24
- Volume
- 60
- Issue
- 7
- Pages
- 923-929
- ISSN
- 0017-5749 (ISSN-L)
- 1468-3288
- OpenAlex
- W2115800864
- Cited by
- 361
- References
- 39
- Citations by year
- 2026: 11 · 2025: 24 · 2024: 28 · 2023: 25 · 2022: 31 · 2021: 31 · 2020: 30 · 2019: 25 · 2018: 21 · 2017: 33 · 2016: 21 · 2015: 21 · 2014: 26 · 2013: 20 · 2012: 10
- FWCI
- 11.97
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Gut (publishedVersion)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Health Sciences › Nursing › Nutrition and Dietetics › Microbial Metabolites in Food Biotechnology
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Keywords
- fructooligosaccharides, Crohn's disease, prebiotics, gut microbiota, Bifidobacterium, Faecalibacterium prausnitzii, dendritic cells, IL-10, interleukin-6, IL-12, CDAI, clinical response, immunomodulation
- MeSH terms
- Adult, Bifidobacterium, Crohn Disease, Dendritic Cells, Double-Blind Method, Feces, Female, Humans, Intestinal Mucosa, Male, Middle Aged, Oligosaccharides, Rectum, Treatment Outcome, Immunity, Mucosal, Medication Adherence, Prebiotics
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