title: One year intermittent rifaximin plus fibre supplementation vs. fibre supplementation alone to prevent diverticulitis recurrence: a proof-of-concept study.
abstract: BACKGROUND
  Evidence supporting appropriate medical therapy to prevent recurrence of colonic diverticulitis is limited. Our goal was to evaluate the potential of rifaximin given periodically in addition to fibre for the prophylaxis of recurrences.
  
  
  METHODS
  We conducted a multicentre, randomized, open controlled study in patients with a recent episode of colonic diverticulitis, currently in remission. Patients received 3.5 g of high-fibre supplementation b.d. with or without one week per month of the non-absorbable antibiotic rifaximin (400 mg b.d.) for 12months. Primary endpoint was recurrence of diverticulitis, encompassing acute symptomatic flare with or without complications, analyzed by multivariable logistic regression analysis and by Cox proportional hazard method.
  
  
  RESULTS
  After randomizing 165 patients, the study was interrupted since the recruitment rate was largely below the minimum anticipated, and the trial was switched from evidence-gathering to proof-of-concept. Recurrences occurred in 10.4% of patients given rifaximin plus fibres vs. 19.3% of patients receiving fibres alone. The logistic analysis adjusted for sex, age, illness duration, time from last episode, disease localization and centre recruitment rate, yielded a significant treatment effect (odds ratio 3.20; 95% confidence interval: 1.16-8.82; P=0.025). Patients with diverticulitis diagnosed since ≥1 year receiving rifaximin also had a lower incidence of recurrences (10%; 95% confidence interval: 2-47% vs. 67%; 95% confidence interval: 37-100%). Both treatments were safe.
  
  
  CONCLUSIONS
  This study represents a proof-of concept of the efficacy of cyclic rifaximin treatment, added to fibre supplements, to reduce the risk of recurrences of diverticulitis in patients in remission.
authors.affiliation: Service of Digestive Diseases, University Hospital Lozano Blesa, IIS Aragón, CIBERehd, University of Zaragoza, Spain. alanas@unizar.es
authors.forename: Angel
authors.initials: A
authors.lastname: Lanas
authors.forename: Julio
authors.initials: J
authors.lastname: Ponce
authors.forename: Angelo
authors.initials: A
authors.lastname: Bignamini
authors.forename: Fermín
authors.initials: F
authors.lastname: Mearin
mesh_terms: D000328:Adult; D000368:Aged; D004043:Dietary Fiber / Q000627:therapeutic use*; D019587:Dietary Supplements; D004238:Diverticulitis / Q000188:drug therapy* / Q000517:prevention & control; D004359:Drug Therapy, Combination; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012294:Rifamycins / Q000009:adverse effects / Q000627:therapeutic use*; D000078262:Rifaximin; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D004043:Dietary Fiber; D005765:Gastrointestinal Agents; D012294:Rifamycins; D000078262:Rifaximin