Nitazoxanide to Treat Exacerbations of Pediatric Inflammatory Bowel Disease (IBD)

Abstract

Purpose: Nitazoxanide (NTZ) is a thiazolide antibiotic indicated for the treatment of Cryptosporidium parvum and Giardia lamblia in adults and children as young as one year of age. NTZ also has excellent in vitro activity against anaerobic bacteria. Unlike many antibiotics used in IBD, NTZ has a unique pharmacokinetic profile in which 2/3 of the drug concentrates in the bowel and 1/3 is absorbed, allowing for drug on both sides of the gastrointestinal lumen. Furthermore, NTZ is well tolerated, not associated with peripheral neuropathies, and does not induce Clostridium difficile disease. This paper documents our clinical experience utilizing NTZ in pediatric patients with exacerbations of IBD. Methods: An IRB approved review of children with IBD experiencing disease exacerbation and treated with NTZ. To qualify for evaluation, patients needed to be on at least maintenance 5-ASA therapy and present with one of the following symptoms: 1) GI bleeding, 2) diarrhea, or 3) abdominal pain. Efficacy was measured as resolution of presenting symptoms, and patient/parent reported overall wellness at follow-up evaluation. Patients with a known infectious origin of disease like Clostridium difficile were excluded from the study. Results: Twenty patients mean age 12 years (range 3-18) met the inclusion criteria. Of these, 9 had Crohn's disease, 6 ulcerative colitis, and 5 indeterminate colitis. NTZ was dosed 100-500 mg (age adjusted) BID for 5-14 days (mean 10 days), 8 patients also received a prednisone course. Symptom presentation was as follows: 70% (14/20) GI bleeding, 60% (12/20) diarrhea, and 85% (17/20) abdominal pain; 25% (5/20), 35% (7/20), and 40% (8/20) presented with 1, 2, and 3 symptoms respectively. Efficacy measures are detailed in Table 1. No significant adverse reactions to therapy were identified.Table 1: Patient outcomesConclusion: Nitazoxanide with or without adjunctive steroids is well tolerated and appears to improve symptoms associated with IBD exacerbations in pediatric patients. Further studies are warranted to confirm this observation. Disclosure: Dr Al-Tawil- Unrestricted educational grant, Romark Laboratories. Dr Eidelwein, Dr Cuevas, Wendy Taylor, and Molly Hansen have nothing to disclose.