Double-Blind Randomized Controlled Trial of Rifaximin for Persistent Symptoms in Patients with Celiac Disease
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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.
KeywordsCeliac disease Small intestine Clinical pharmacology Diarrhea Malabsorption Microbiology Symptom score or index
This study was funded in part by Salix Pharmaceuticals who provided the study medication and placebo. The preparation of this paper, including data analysis and writing, was not funded and was conducted by the authors exclusively.
Conflict of interest
Drs. Peter Green, Matthew Chang, Maria Minaya, Jianfeng Cheng, Bradley Connor, Suzanne Lewis have no personal interests to declare.
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