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P602 CD-TREAT a novel dietary therapy of active Crohn’s disease using the exclusive enteral nutrition paradigm

V. Svolos*1, R. Hansen2, U. Z. Ijaz3, L. Gervais2, H. Duncan2, R. Tayler2, A. Barclay2, D. Flynn2, V. Garrick2, L. Curtis2, E. Buchanan2, T. Cardigan2, D. R. Gaya4, S. Milling5, R. K. Russell2, K. Gerasimidis1

1Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK, 2Department of Paediatric Gastroenterology, Hepatology and Nutrition, Royal Hospital for Children, Glasgow, UK, 3School of Engineering, University of Glasgow, Glasgow, UK, 4Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK, 5Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK

Background

Treatment with exclusive enteral nutrition (EEN) in Crohn’s disease (CD) offers a nutritional therapy paradigm that could potentially be replicated by less restrictive dietary therapies, thereby improving compliance and tolerability. On this premise, we developed a food-based diet (CD-TREAT) to replicate the efficacy of EEN. Using a combination of a randomised control trial in healthy volunteers and experiments with animal models we demonstrated that CD-TREAT replicates the EEN effect on gut microbiome and ameliorates rat ileitis.1,2 Following these pre-clinical studies, we aimed to assess the effect of CD-TREAT diet on gut inflammation and clinical efficacy, using a pilot trial in children with active CD.

Methods

CD-TREAT is a personalised diet which replicates EEN composition using solid food. The translational efficacy of an 8-week treatment course with CD-TREAT was explored in a pilot study of five children with active luminal CD. In order to assess compliance, participants were instructed to record their dietary intake daily during the intervention using a food checklist. The primary outcome was clinical response (weighted Paediatric Crohn’s disease Activity Index-wPCDAI fall ≥ 17.5) or clinical remission (wPCDAI < 12.5) at 8 weeks. Secondary outcomes included changes in faecal calprotectin (FC), serum albumin and C-reactive protein (CRP).

Results

From the enrolled CD children, 80% (4/5) clinically responded to CD-TREAT (wPCDAI fall greater than 17.5) and 60% (3/5) entered clinical remission (wPCDAI<12.5). FC decreased by a mean (SD) of 918 (555) mg/kg or 55% of baseline values. One patient had raised CRP and low albumin at CD-TREAT initiation and both inflammatory markers normalised at treatment completion. There were no differences between the prescribed and actual CD-TREAT intake of the patients, indicating high compliance to the dietary treatment protocol.

Conclusion

The current pilot trial in children with active CD demonstrated, for the first time, that CD-TREAT improves disease activity and inflammatory markers as induction treatment in active CD. The high tolerability of CD-TREAT suggests that this personalised, ordinary food-based diet could replace EEN as the nutritional therapy of choice to treat active luminal CD.

References

1. Svolos V, Hansen R, Hughes K, et al. The impact of ‘Crohn’s Disease-TReatment-with-EATing’diet (CD-TREAT diet) and exclusive enteral nutrition on healthy gut bacteria metabolism. J Crohn's Colitis 2016;10:S14–S15.

2. Svolos V, Hansen R, Ijaz UZ, et al. Dietary manipulation of the healthy human and colitic murine gut microbiome by CD-TREAT diet and exclusive enteral nutrition; a proof of concept study. J Crohn’s and Colitis 2017;11:S29–S30.