Double-Blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients with Celiac Disease
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- Chang, M.S., Minaya, M.T., Cheng, J. et al. Dig Dis Sci (2011) 56: 2939. doi:10.1007/s10620-011-1719-6
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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.
To determine the effect of rifaximin on gastrointestinal symptoms and lactulose-hydrogen breath tests in patients with poorly responsive celiac disease.
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.
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.
Rifaximin does not improve patients’ reporting of gastrointestinal symptoms and hydrogen breath tests do not reliably identify who will respond to antibiotic therapy.