Fructo-oligosaccharides in Crohn s disease: a prospective randomised double blind controlled trial
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1 Fructo-oligosaccharides in Crohn s disease: a prospective randomised double blind controlled trial Principal investigator: Dr James Lindsay St Bartholomew's Hospital and The Royal London Hospital Queen Mary School of Medicine and Dentistry, University of London
2 Pathogenesis of Crohn s disease: balance within the mucosal immune system Environmental factors Genetic predisposition Inflammatory Pathways Regulatory pathways Infectious agent Luminal content / microbiota
3 Regulatory pathways in Crohn s disease: interaction between luminal content and mucosa Bacteriocin / contact inhibition Short-chain fatty acids Y Epithelial defence Permeability Y Innate immune function Y Y DC TLR Y Y IL-12, IL-18, IL-23 Y T cell Th1 IL-10, TGF-β Treg
4 Regulatory pathways in Crohn s disease interaction between microbiota and adaptive responses Probiotic VSL enhances DC immunoregulatory function in vitro 60 * * * * * L.acidophilus L.casei L.plantarum L.delbrueckii B.longum B.infantis B.breve S. thermophilus S.faecium E.coli Nissle VSL# Hart et al, Gut, 2004; 53: 1602
5 Prebiotics: Fructo-oligosaccharide / inulin CH2OH O OH Not hydrolyzed in upper GI tract HO HOCH2 O OH HO O CH2 Selectively fermented HOCH2 OH O HO O CH2 Increase faecal and mucosal bifidobacteria OH O n Produce short-chain fatty acids HOCH2 OH O HO CH2 O Enhance calcium absorption
6 Open label trial of fructo-oligosaccharide in Crohn s disease Increased DC IL-10 Reduced disease activity 60 P= P= Baseline FOS HBI score Baseline FOS
7 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease Inclusion criteria Crohn s disease for at least 3/12 Radiological / endoscopic diagnosis Active disease (CDAI ) Raised inflammatory markers CRP or ESR or Platelet count Stable medication Prednisolone <10mg Aged No pre / probiotic No recent antibiotics Must have functioning colon Not pregnant or lactating No other significant disease
8 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease Outcome measures Primary endpoint Clinical response week 4 Secondary endpoints Remission week 4 Response / remission week 12 Change in HBI / CDAI Reduction in CRP weeks 4/12 Microbiological endpoints Baseline faecal / mucosal microbiota Change in microbiota at week 4 / 12 Immunological endpoints LP dendritic cell phenotype at baseline LP dendritic cell phenotype at week 4 Increase in IBDQ
9 Schematic diagram of study visits 110 patients with mild to moderate Crohn s Sigmoidoscopy / biopsy, Bloods Stool sample, Urine sample, FFQ / IBDQ / CDAI / HBI FOS n=55 Placebo n=55 4 week treatment period Sigmoidoscopy, Bloods Stool sample, Urine sample, FFQ / IBDQ / CDAI / HBI 12 week follow up period Bloods Stool sample, Urine sample, FFQ / IBDQ / CDAI / HBI
10 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease: interim results 96 pts screened 47 pts recruited 8 pts withdrawn Baseline CDAI 400 Sex ratio 60 Age Smoking status M F Ex never Current Non
11 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease: baseline microbiota Baseline microbiota is not affected by disease location Colonic only (N=8) Ileo-colonic (N=30) sig Total bacteria 10.4 (0.3) 10.2 (0.5) NS Total cells 10.4 (0.3) 10.3 (0.4) NS Bifidobacteria 10 (0.3) 9.9 (0.5) NS Bacteroides 9.9 (0.3) 9.8 (0.5) NS Clostridia Sp 10 (0.4) 9.7 (0.5) NS No effect of baseline CDAI / medication / age / years since diagnosis
12 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease: baseline microbiota Effect of smoking on baseline microbiota in patients with Crohn s disease Smokers Non-smokers sig %Bac (EUB) 47.3 (14.8) 36.5 (14.9) p=0.043 %Bac (DAPI) 39.6 (12) 31.5 (12.7) p=0.070 Smokers Non-smokers sig Bac/Bif 1.1 (0.4) 0.9 (0.3) p=0.019
13 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease : baseline immunology
14 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease : baseline immunology Compared with patients with no detectable IL-10 producing DC, those with IL-10 positive colonic DC have significantly higher: 1. Faecal concentrations of total bacteria (10.6±0.2 vs 10.2±0.4 log10/g, p=0.049) 2. Bifidobacteria (10.3±0.2 vs 9.8±0.5 log10/g, p=0.039) 3. Bacteroides (10.2±0.3 vs 9.6±0.5 log10/g, p=0.025) There were no significant differences in individual bacterial strains and concentrations when comparing IL-6 or IL-12p40 positive DC, with IL-6 and IL12p40 negative DC
15 Double blind placebo controlled trial of FOS vs placebo in Crohn s disease : conclusions Microbiota exert inflammatory and immunoregulatory effect on the intestine Prebiotics increase bifidobacteria and enhance regulatory responses DBPCT ongoing: recruitment on schedule
16 The London Prebiotic Research Group: Acknowledgments James Lindsay Kevin Whelan Jeremy Sanderson Andy Stagg Mike Kamm & Ailsa Hart Alastair Forbes Charlotte Hedin Andreas Koutsoumpas Jane Benjamin Sophie Plamondon Siew Ng
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