Prevalence of and risk factors for Helicobacter pylori infection in children under 64 months in Thimphu, Bhutan, and introducing the new in-house immunochromatography test kit: a cross-sectional study.

BACKGROUND

Helicobacter pylori (H. pylori) is a lifelong infection, often acquired in childhood and persisting throughout life, that can lead to serious gastric diseases, including gastric cancer in adults. While asymptomatic in most children, it may cause extraintestinal manifestations affecting growth, necessitating distinct pediatric management strategies-particularly in countries with a high risk of gastric cancer. Accurate diagnosis is critical in high-risk populations. The stool antigen test is a reliable, non-invasive method for young children. Despite Bhutan's high H. pylori burden, diagnostic tools remain scarce. This study aimed to determine the prevalence and risk factors of H. pylori infection in Bhutanese children and validate a new in-house immunochromatography test (the A-ICT) kits.

METHODS

A cross-sectional study was conducted in 2023 among children under 64 months of age at three immunization clinics in Thimphu. H. pylori antigen in stool was detected using an ICT kit. After obtaining informed consent, parents completed questionnaires. Data were analyzed using STATA version 14.2 and R version 4.4.1.

RESULTS

A total of 226 children (mean age 33.28 months) participated in the study. The A-ICT kit showed high concordance with the commercial kit (Kappa 0.84 [95% CI: 0.78-0.89]) and excellent sensitivity (0.96) and specificity (0.95). The prevalence of H. pylori was 19.54% (95% CI:14.95-24.83). Risk factors included increasing age, having two or more siblings, and fathers who were farmers/wagers, and who worked in government/private sector. Children who were fed with or who ate using a spoon had a significantly lower risk of H. pylori infection than those who were fed or ate with fingers (p < 0.05).

CONCLUSIONS

The A-ICT kit demonstrated remarkable sensitivity and specificity. Improvements in hygiene and sanitation related to child feeding practices are essential. Awareness programs should target large families and individuals employed in the formal sector, including both household and workplace settings. The validation of the A-ICT is a significant step toward a gastric cancer prevention program that facilitates early diagnosis and H. pylori eradication. The test kit is highly recommended for H. pylori screening and the confirmation of eradication post-treatment given its accuracy, rapidity, and simplicity in execution.