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Helicobacter pylori Eradication Rate Using Stool Antigen Test in Vietnamese Children: A Prospective Multicenter Study
Tu Cam Nguyen1,2, Annie Robert3, Thu Hien Anh Pham4
1From the Department of Gastroenterology, City Children's Hospital, Ho Chi Minh City, Vietnam.
Insights
The stool antigen test (HpSA) reliably detects Helicobacter pylori infection in children. However, low eradication rates indicate a need for improved treatment strategies in Vietnam.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Diagnostic Accuracy
Background:
- Helicobacter pylori (H. pylori) infection is a common cause of pediatric gastrointestinal issues.
- Accurate diagnosis and assessment of treatment efficacy are crucial for managing H. pylori infections in children.
Purpose of the Study:
- To evaluate the diagnostic performance of a monoclonal immunoassay stool antigen test (HpSA) for H. pylori infection in children.
- To assess the effectiveness of H. pylori eradication treatments using HpSA.
- To determine the optimal cutoff value for HpSA in this pediatric population.
Main Methods:
- A prospective study involving 394 children undergoing endoscopy in Ho Chi Minh City.
- HpSA was performed on stool samples collected before and after treatment.
- Biopsy-based tests served as the gold standard for diagnosing H. pylori infection.
Main Results:
- H. pylori infection was prevalent (78%) in the study cohort, with common symptoms including epigastric pain and vomiting.
- HpSA demonstrated high diagnostic accuracy (88.4%), with sensitivity of 87.4% and specificity of 95.2%.
- The eradication rate was low (56.1% per-protocol, 27.9% intention-to-treat), with variations based on gender, nutritional status, and bacterial strain.
Conclusions:
- HpSA is a reliable tool for diagnosing H. pylori infection and monitoring eradication in pediatric studies.
- The observed low eradication rates in Vietnamese children underscore the necessity for optimized intervention strategies.
Objectives:
This study assessed the diagnostic value of a monoclonal immunoassay stool antigen test (HpSA) for Helicobacter pylori (H. pylori) infection and the eradication outcomes.
Methods:
Children undergoing digestive endoscopy at 2 Children's Hospitals in Ho Chi Minh City were recruited. Treatment was offered to H. pylori-infected children. Stool samples were collected on the same day as the endoscopy procedure and after 6 weeks post-treatment for HpSA. Diagnostic value and optimal cutoff of HpSA were assessed using biopsy-based tests as the gold standard. Eradication was defined as a negative HpSA post-treatment. Ethical approval was obtained, and informed consent was signed by the participants.
Results:
In total, 394 patients participated in the study. The most common symptoms were epigastric pain (74.6%) and vomiting (37.3%). H. pylori status was positive in 78% of patients (306/394), doubtful in 10.1%, and negative in 12.2%. HpSA was positive in 73.2% (142/194). Excluding doubtful infections, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of HpSA were 87.4%, 95.2%, 99.2%, 51.3%, and 88.4%, respectively. The optimal cutoff value of 0.148 provided similar accuracy to the recommended cutoff. The eradication rate was 56.1% in per-protocol analysis and 27.9% in intention-to-treat analysis. Treatment success was higher in boys, but lower among malnourished children and those infected with cagA+ strains.
Conclusions:
The HpSA is reliable for identifying H. pylori infection in epidemiological studies and assessing eradication outcomes. The low eradication rate highlights the need for an appropriate intervention strategy in Vietnamese children.
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