PC3004: Comparative Study of H.pylori Eradication Rates of High and Frequent Dose of Omeprazole and Amoxicillin Dual Therapy versus Standard Triple Therapy in Children

Background: . The importance of reducing antibiotic use in pediatric patient is well recognized especially after recent studies indicated that multiple antibiotics used in h pylori eradication therapy can disrupt the gut micobiota composition which may be associated with different diseases. Therefore, we aimed to re- evaluate the efficacy and safety of high and frequent doses of PPI-AMO dual therapy for H. pylori eradication as a first- line therapy in children.

Methods: This is a randomized controlled trail conducted on 156 consecutive children with H pylori infection, 2-14 years , who underwent upper gastrointestinal endoscopy because of dypepsia.Studied children were randomly assigned to one of two regimens: 1-dual therapy with amoxicillin (50mg/kg/day) and omeprazole (3mg/kg/day) three time daily for 2 weeks. 2- triple therapy with amoxicillin(50mg/kg/day), metronidazole (20 mg/kg/day) and omeprazole (1mg/kg/day) twice daily for 2 weeks. Both groups are comparable as regard demographic , clinical and endoscopic data. H. pylori status was determined by rapid urease test and histopathology before treatment and by stool Ag 4 weeks after cessation of any medication.

Results: One hundred and forty three children completed the study. The intention-to-treat(ITT) and per-protocol(PP) eradication rates were74.5% and 80.6% respectively, with dual therapy and 78%and 85% ,respectively, with triple therapy .(ITT ,p0.572; PP ,p0.391).The adverse effects ( diarrhea, nausea, abdominal discomfort and headache) , were more frequently recorded in triple therapy group (34%) than dual therapy group ( 20.5% ) ( p< 0.049).None of the patients stopped taking medication because of the side effects.

Conclusion: High-dose PPI-amoxicillin dual therapy is comparable to the stander triple therapy for H. pylori eradication in children, while reducing the use of antibiotic. Therefore, the use of dual therapy my provide an acceptable alternative first line therapy for H.pylori eradication in children which might lower the risk of future antimicrobial resistance and unpredicted diseases associated with the compositional changes of gut microbiota .

This study has been registered at Pan African Clinical Trials Registry ,Cochrane South Africa, under identifier PACTR201807134057681.