A New Four-day Regimen with Dexlansoprazole, Moxifloxacin, Amoxicillin, Nitazoxanide, and Doxycycline (DeMAND) in Helicobacter Pylori Therapy: An Open-label Randomized Clinical Trial

Abstract

Purpose: Treatment failure for Helicobacter Pylori is due to antimicrobial resistance, and recrudescence. This study utilizes shorter regimen for better compliance and efficacy. Methods: 75 (N=75)-naïve dyspeptic patients underwent upper endoscopy with biopsies with positive DNA PCR H. pylori and stool H. pylori antigen. All were randomized into three arms: DeMAND Group (n=25): Oral Dexlansoprozole 60 mg, Moxifloxacin 400 mg, Amoxicillin 1 gram; Doxycycline 100 mg once, and Nitazoxanide 500 mg twice daily for four days; LOAD Group (n=25) oral: Levofloxacin 250 mg, Omeprazole 40 mg, and Doxycycline 100 mg once a day, with Alinia 500 mg twice daily for seven days; LAC Group (n=25) with traditional regimen of lansoprazole 15 mg, Amoxicillin I gram, Clarithromycin 500 mg twice daily for seven days. Exclusion: active bleeding, pregnancy, antimicrobial hypersensitivity, and use of antisecretory and antimicrobials within eight weeks. Results: 68 patients (90.7%) completed with seven (9%) total dropouts. Side events were minor rash, dizziness, diarrhea and palpitations. 30 days post-therapy stool antigen test of H. pylori was negative in 19/25 patients (76%-ITT analysis) in Group A, 22/25 (88%) in LOAD Group, and 18/25 (72%) in LAC Group, with no significant difference in eradication rate amongst all arms (χ2=2.1, p=0.36). Per-protocol analysis revealed no difference (χ2=2.4, p=0.30) in eradication rate amongst DeMAND (19/23=82.6%), LOAD (22/23=95%), LAC (18/22=81%). Conclusion: The 4-day DeMAND regimen is safe and as effective as the LOAD and LAC therapy for eradicating H. pylori, with shorter length and comparable cost benefits. Larger trial warrants validation.