The Eradication of Helicobacter Pylori [H.pylori] in children

Comparison efficacy the three- drug regimen of Helicobacter Pylori eradication Amoxicillin, Omeprazole, with Clarithromycin or Azithromycin in children

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013112115475N1

Enrollment

Unknown

Registered

2014-10-07

Start date

2014-04-30

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

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

Interventions

Intervention 1: Intervention 1: Azithromycin manufactured by Tehran Shimi Company and Khrazmi 10 mg/kg/day once a day for 6 days using with Amoxicillin manufactured by Farabi Company 50 mg/kg/day ever

Treatment - Drugs

Intervention 1: Azithromycin manufactured by Tehran Shimi Company and Khrazmi 10 mg/kg/day once a day for 6 days using with Amoxicillin manufactured by Farabi Company 50 mg/kg/day every 12 hours for 1

Intervention 2: Clarithromycin developed by Chemidarou and Rouzdarou Company 15 mg /kg/day every 12 hours for 10 days using with Amoxicillin and Omeprazole.

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Two to 15 year old children with gastrointestinal symptoms associated with Helicobacter Pylori that need upper Gastro Intestinal whose Gastric biopsy diganosed Helicobacter Pylori Endoscopy and have been referred to the Amirkola Children’s Hospital. Exclusion criteria: Use of antibiotics 2 months ago; children beyond ages of 2 to 15 years; drug allergies to medications used in the study; chronic liver and renal disease; taking non steroidal anti inflammatory drugs; patients who have been previously treated for Helicobacter Pylori.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The detection Status of Helicobacter Pylori antigen in stool. Timepoint: Four to 6 weeks after the treatment is over. Method of measurement: Check on the stool antigen from Helicobacter Pylori point of view in a Monoclonal Method with Helicobacter Antigen Quick kit.	—

Secondary

Measure	Time frame
The status of drug tolerance and side effects. Timepoint: Within treatment till the end of treatment span. Method of measurement: Check on the Helicobacter Pylori stool antigen.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Shirdel

Amirkola Children’s Hospital

dr.h.shirdel@gmail.com+98 11 3235 4951

Outcome results

None listed

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