Nitazoxanide for the Treatment of SIBO Related Gastrointestinal Symptoms in Pediatric Population

Abstract

Purpose: Many pediatric patients present with symptoms of Small Intestinal Bacterial Overgrowth (SIBO). Intestinal anaerobic bacteria are known to contribute to the symptoms exhibited by these patients. However, without a definitive test to confirm SIBO, many pediatric practitioners empirically treat these patients with a course of antibiotics with or without probiotics. Nitazoxanide (NTZ) is a first in class thiazolide antibiotic with a targeted anaerobic antibacterial activity, placebo-like safety profile, high gastrointestinal (GI) concentration, and has limited to no activity against probiotic species. To date no studies have evaluated the empiric use of NTZ for the treatment of GI related symptoms in pediatric SIBO patients. Methods: A chart review was performed on patients treated with NTZ from February 2006 to May 2007. The diagnosis of SIBO was made by the attending physician based on the patient's history, signs and symptoms. Efficacy was measured as resolution of the patient's GI related symptoms, 3–8 weeks after the end of therapy. Primary markers for resolution included: abdominal pain, diarrhea, constipation, bloating, and/or flatulence. Overall 22 patients met the inclusion criteria for review. Results: Of the 22 patients treated with NTZ, 13 (median age – 6.8 years) patients returned to the office for adequate follow up. Nine patients were prescribed NTZ for SIBO and have not returned to the office for any GI complaints. The range of NTZ doses used was 100 mg – 500 mg BID for 5–10 days depending on age of the pediatric patient. The mean dose and duration was 422 mg/d for 7.7 days. The most common dose was 200 mg BID for 10 Days (N = 5). All patients treated with NTZ and a probiotic (13/13 [100%]) had complete resolution of symptoms that were present at initial visit. No clinically significant adverse reactions attributable to NTZ were identified during the study. Conclusion: Nitazoxanide appears to be a safe and effective therapy for the empiric treatment of SIBO related GI symptoms in pediatric patients. Larger controlled clinical trials are warranted to support these findings.Table. Results