Abstract
Eradication of Helicobacter pylori (H. pylori) infection in children is challenging due to increased antibiotic resistance and decreased effectiveness of the current therapeutic choices, especially in developing countries. The purpose of this study is to compare the efficacy and safety of triple therapy (TT), sequential therapy (ST), hybrid therapy (HT), concomitant therapy (CT), and ciprofloxacin-based triple therapy (CTT) as an empirical therapy for H. pylori eradication in children. In this randomized controlled trial, 200 children (aged between 3 and 16 years) with both positive rapid urease test and histopathology for H. pylori infection were included. Patients were randomly assigned to receive either TT, ST, HT, CT, or CTT. The eradication status was evaluated using a stool antigen test (SAT) 4 weeks after stoppage of antibiotic therapy and 2 weeks after stoppage of proton pump inhibitors. SAT was performed using an ELISA monoclonal antibody-based kit. The most common presenting symptom was epigastric pain (79%). The most common endoscopic findings were gastric antral erythema (98%) and antral nodularity (54.5%). All gastric biopsies showed superficial lamina propria infiltration with plasma cells and lymphocytes. Active gastritis with neutrophils infiltration was seen in 75% of the cases. Gastric atrophy and intestinal metaplasia were uncommon histopathological findings (8.5% and 1%, respectively). The eradication rates for TT, ST, HT, CT, and CTT were 70%, 77.5%, 80%, 85%, and 90%, respectively, with the latter achieving a statistically significant difference when compared with TT (p = 0.025). The rate of occurrence of adverse effects among different regimens was not statistically different. CONCLUSION: As an empirical treatment for children with H. pylori infection, CTT is safe and provides the highest eradication rate. HT, ST, and CT might not be superior to TT. TRIAL REGISTRATION: This study was registered at the Pan African Clinical Trials Registry, Cochrane South Africa, under the identifier PACTR202201686010590. Date of registration: 04 January 2022. WHAT IS KNOWN: • Triple therapy has been the standard eradication regimen for pediatric H. pylori infection. The efficacy of triple therapy has decreased in many countries due to increased antibiotic resistance. WHAT IS NEW: • This randomized controlled trial is the first to compare triple therapy, sequential therapy, hybrid therapy, concomitant therapy, and ciprofloxacin-based triple therapy for the eradication of pediatric H. pylori infection. Triple therapy exhibited the lowest eradication rate among the studied regimens, suggesting it may not be an adequate therapeutic option for infected children. Ciprofloxacin-based triple therapy appears to be a safe and effective therapeutic choice for pediatric H. pylori infection. Additionally, this study provides the first reported eradication rate of hybrid therapy in pediatric H. pylori infection.