title: Lack of efficacy of a reduced microparticle diet in a multi-centred trial of patients with active Crohn's disease.
abstract: OBJECTIVE
  Dietary microparticles, which are bacteria-sized and non-biological, found in the modern Western diet, have been implicated in both the aetiology and pathogenesis of Crohn's disease. Following on from the findings of a previous pilot study, we aimed to confirm whether a reduction in the amount of dietary microparticles facilitates induction of remission in patients with active Crohn's disease, in a single-blind, randomized, multi-centre, placebo controlled trial.
  
  
  METHODS
  Eighty-three patients with active Crohn's disease were randomly allocated in a 2 x 2 factorial design to a diet low or normal in microparticles and/or calcium for 16 weeks. All patients received a reducing dose of prednisolone for 6 weeks. Outcome measures were Crohn's disease activity index, Van Hees index, quality of life and a series of objective measures of inflammation including erythrocyte sedimentation rate, C-reactive protein, intestinal permeability and faecal calprotectin. After 16 weeks patients returned to their normal diet and were followed up for a further 36 weeks.
  
  
  RESULTS
  Dietary manipulation provided no added effect to corticosteroid treatment on any of the outcome measures during the dietary trial (16 weeks) or follow-up (to 1 year); e.g., for logistic regression of Crohn's disease activity index based rates of remission (P=0.1) and clinical response (P=0.8), in normal versus low microparticle groups.
  
  
  CONCLUSIONS
  Our adequately powered and carefully controlled dietary trial found no evidence that reducing microparticle intake aids remission in active Crohn's disease.
authors.affiliation: Gastrointestinal Laboratory, The Rayne Institute, St Thomas' Hospital, London, UK. miranda.lomer@kcl.ac.uk
authors.forename: Miranda C E
authors.initials: MC
authors.lastname: Lomer
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Grainger
authors.forename: Roland
authors.initials: R
authors.lastname: Ede
authors.forename: Adrian P
authors.initials: AP
authors.lastname: Catterall
authors.forename: Simon M
authors.initials: SM
authors.lastname: Greenfield
authors.forename: Russell E
authors.initials: RE
authors.lastname: Cowan
authors.forename: F Robin
authors.initials: FR
authors.lastname: Vicary
authors.forename: Anthony P
authors.initials: AP
authors.lastname: Jenkins
authors.forename: Helen
authors.initials: H
authors.lastname: Fidler
authors.forename: Rory S
authors.initials: RS
authors.lastname: Harvey
authors.forename: Richard
authors.initials: R
authors.lastname: Ellis
authors.forename: Alistair
authors.initials: A
authors.lastname: McNair
authors.forename: Colin C
authors.initials: CC
authors.lastname: Ainley
authors.forename: Richard P H
authors.initials: RP
authors.lastname: Thompson
authors.forename: Jonathan J
authors.initials: JJ
authors.lastname: Powell
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002136:Calcium, Dietary / Q000008:administration & dosage; D003092:Colitis / Q000178:diet therapy; D003424:Crohn Disease / Q000178:diet therapy*; D004032:Diet; D004781:Environmental Exposure / Q000009:adverse effects; D005260:Female; D005503:Food Additives / Q000008:administration & dosage; D006801:Humans; D007079:Ileitis / Q000178:diet therapy; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D002136:Calcium, Dietary; D005503:Food Additives