title: Double-blind randomized controlled trial of rifaximin for persistent symptoms in patients with celiac disease.
abstract: BACKGROUND
  Small intestinal bacterial overgrowth (SIBO) is one cause of a poor response to a gluten-free diet (GFD) and persistent symptoms in celiac disease. Rifaximin has been reported to improve symptoms in non-controlled trials.
  
  
  OBJECTIVE
  To determine the effect of rifaximin on gastrointestinal symptoms and lactulose-hydrogen breath tests in patients with poorly responsive celiac disease.
  
  
  METHODS
  A single-center, double-blind, randomized, controlled trial of patients with biopsy-proven celiac disease and persistent gastrointestinal symptoms despite a GFD was conducted. Patients were randomized to placebo (n = 25) or rifaximin (n = 25) 1,200 mg daily for 10 days. They completed the Gastrointestinal Symptom Rating Scale (GSRS) and underwent lactulose-hydrogen breath tests at weeks 0, 2, and 12. An abnormal breath test was defined as: (1) a rise in hydrogen of ≥20 parts per million (ppm) within 100 min, or (2) two peaks ≥20 ppm over baseline.
  
  
  RESULTS
  GSRS scores were unaffected by treatment with rifaximin, regardless of baseline breath tests. In a multivariable regression model, the duration of patients' gastrointestinal symptoms significantly predicted their overall GSRS scores (estimate 0.029, p < 0.006). According to criteria 1 and 2, respectively, SIBO was present in 55 and 8% of patients at baseline, intermittently present in 28 and 20% given placebo, and 28 and 12% given rifaximin. There was no difference in the prevalence of SIBO between placebo and treatment groups at weeks 2 and 12.
  
  
  CONCLUSIONS
  Rifaximin does not improve patients' reporting of gastrointestinal symptoms and hydrogen breath tests do not reliably identify who will respond to antibiotic therapy.
authors.affiliation: Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA.
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Chang
authors.forename: Maria T
authors.initials: MT
authors.lastname: Minaya
authors.forename: Jianfeng
authors.initials: J
authors.lastname: Cheng
authors.forename: Bradley A
authors.initials: BA
authors.lastname: Connor
authors.forename: Suzanne K
authors.initials: SK
authors.lastname: Lewis
authors.forename: Peter H R
authors.initials: PH
authors.lastname: Green
mesh_terms: D000328:Adult; D001944:Breath Tests; D002446:Celiac Disease / Q000188:drug therapy* / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D006859:Hydrogen / Q000378:metabolism; D007792:Lactulose / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D012044:Regression Analysis; D012294:Rifamycins / Q000627:therapeutic use*; D000078262:Rifaximin; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D012294:Rifamycins; D007792:Lactulose; D006859:Hydrogen; D000078262:Rifaximin