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Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children

Comparative evaluation of triple therapy with high dose amoxicillin versus bismuth-based therapy in second-line therapy for eradication of helicobacter pylori infection in children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191022045195N1
Enrollment
50
Registered
2020-01-08
Start date
2019-11-11
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H.pylori Gastritis. Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Interventions

Intervention 1: Intervention group 1: Patients will be treated with omeprazole, metronidazole, high-dose amoxicillin, and folic acid over a 14-day period. It should be noted that omeprazole is adminis

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children with Helicobacter pylori infection who are known to be resistant to the first stage of eradication

Exclusion criteria

Exclusion criteria: Patients who have had a positive history of taking drugs such as antibiotics during the last 4 weeks,  Bismuth, proton pump inhibitor, histamine receptor antagonist 2 or non-steroidal anti-inflammatory drug are excluded

Design outcomes

Primary

MeasureTime frame
The percentage of patients with Helicobacter pylori antigen in the stool sample is negative. Timepoint: Helicobacter pylori antigen assay is performed within 4 to 6 weeks after completion of treatment. Method of measurement: Helicobacter pylori antigen in stool sample by ELISA.

Secondary

MeasureTime frame
Percentage of people with side effects while taking the drug. Timepoint: From the beginning of the drug to the end of the study. Method of measurement: Self-expression of the patient, parents or carers.;Percentage of patients who were fully compliant with medication. Timepoint: Up to 4 weeks after starting the drug. Method of measurement: Self-expression of the patient, parents or carers.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRita Bagherian

Qazvin University of Medical Sciences

r.bagherian@qums.ac.ir+98 28 3333 4807

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026