School-based hygiene intervention to prevent Helicobacter Pylori infection among children (SHIP HOPE): a cluster-randomized controlled trial

Helicobacter pylori ( H. pylori ) is a major cause of gastric cancer and is typically acquired during childhood. Preventing infection in uninfected children is a promising strategy; however, the effectiveness of hygiene-based interventions remains uncertain. This study aimed to determine whether a comprehensive school-based hygiene intervention could reduce H. pylori infection in children. This cluster-randomized controlled trial recruited children from 10 primary schools in Linqu County, China. Schools were randomized (1:1) to either the intervention or control group. Within each school, two eligible classes in each of Grades 2–4 were enrolled. The intervention, a “Good Hygiene Practice Package” comprising children’s education, caregiver education, and school hygiene promotion, was delivered to all enrolled classes in intervention schools, whereas the enrolled classes in the control schools continued to receive the usual health education provided by their schools, without H. pylori -specific content or caregiver interventions. Participants underwent follow-up assessments at 3 months (April 2023) and at 1 year after the intervention (December 2023). The primary outcomes were the incidence and prevalence at 1 year after the intervention, assessed using stool antigen testing. A total of 2514 children and their caregivers were included. Baseline H. pylori infection rates in children was 4.1% in the intervention group and 6.0% in the control group. At 1 year after the intervention, no statistically significant difference was observed in the prevalence (7.1% vs. 6.7%; OR 1.25; 95% CI, 0.37–4.19) or incidence (5.9% vs. 5.5%; OR 1.14; 95% CI, 0.34–3.88) of H. pylori infection. In contrast, children in the intervention group demonstrated substantially greater knowledge of H. pylori both at 3 months and at 1 year after the intervention (71.3% vs. 17.3%, and 66.5% vs. 30.4%, respectively), although improvements in self-reported hygiene practices attenuated over time. School absence owing to diarrhea and growth outcomes were similar between groups. These findings indicate that improvements in knowledge and self-reported hygiene behaviors were not accompanied by a detectable reduction in H. pylori infection. However, the wide confidence intervals indicate uncertainty in the effect estimates, underscoring the need for larger studies with longer follow-up and more sustained, family-centered prevention strategies. Chinese Clinical Trial Registry ( https://www.chictr.org.cn/index.aspx ), ChiCTR2200056191. Registered on 1 February 2022.