Table 3. Other outcomes measures description.
| Outcome measure | Measure description |
| Prevalence of H. pylori persistent infection in adolescents in Colina, Temuco and Aysén. | Two initial UBT tests will be performed separated by 1 month; a third UBT test will be obtained if there is a discordance in results of the first two tests. |
| Effect of treatment on frequency of clarithromycin resistance comparing those subjects who would not eradicate with non-treated individuals. | Stool evaluation for presence of Clarithromycin resistance genes will be performed in stool samples obtained before eradication (30 in each group), and within 6 months after the positive UBT sample indicating non-eradication in conjunction with testing of a similar number of non-treated UBT positive subjects (20 in each group, including 10 treated and non-eradicated subjects). |
| Overall reinfection rates in adolescents with successful eradication after treatment. | UBT test performed 1 month after the last day of treatment to confirm eradication, and then 6 months after treatment and, subsequently, every 6 months to evaluate reinfection up to 24 months post-treatment. |
| Change in the percentage of adolescents, which have ‘gastric disease’ according to gastroenterologist examination from posteradication to postreinfection. | Clinical evaluations by a gastroenterologist or trained physician, blinded to the subject’s treatment arm, will be conducted after successful eradication (2–4 months post-treatment), and subsequently, at 9–12 months and 18–24 months post-treatment to assess specific GI signs and symptoms and their changes in relation to reinfection during this follow-up period. |
| Change in blood levels of biomarkers indicative of gastric damage postreinfection as compared with postsuccessful eradication. | A blood sample will be collected within 6 months after the positive UBT sample indicating reinfection. Biomarkers will be analysed as described in primary endpoints. |
| Change in gut microbiome alpha-diversity index postreinfection as compared with postsuccessful eradication. | A stool sample will be collected within 6 months after the positive UBT sample indicating reinfection. Gut microbiome analysis will be performed according to what is described in secondary endpoints. |
| Change in faecal Escherichia coli and Enterococcus AMR rates postreinfection as compared with postsuccessful eradication. | A stool sample will be collected within 6 months after the positive UBT sample indicating reinfection. AMR will be analysed as described in secondary endpoints. |
AMRantimicrobial resistanceH. pyloriHelicobacter pyloriUBTurea breath test