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Efficacy of sequential and standard therapy on Helicobacter pylori eradication in children

Comparison of sequential and standard therapy in Helicobacter pylori eradication in children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013122515929N1
Enrollment
60
Registered
2014-03-13
Start date
2014-02-19
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. Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Interventions

Intervention 1: Intervention 1: The sequential regimen is a dual therapy including omeprazole (Dr. Abidi Co.) 1mg/Kg plus amoxicillin (Farabi Co.) 25mg/Kg (both twice daily) given for the first 5 days
Treatment - Drugs
Intervention 1: The sequential regimen is a dual therapy including omeprazole (Dr. Abidi Co.) 1mg/Kg plus amoxicillin (Farabi Co.) 25mg/Kg (both twice daily) given for the first 5 days followed by a t
Intervention 2 (Control): Triple therapy with omeprazole (DR. Abidi Co.) 1mg/Kg(30 days), plus amoxicillin (Farabi Co.) 25mg/Kg (10 days)and metronidazole (Tehranshimi Co.) 10mg/Kg (10 days).all drugs

Sponsors

Vice chancellor for research, Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Gastrointestinal symptoms including epigastric tenderness,abdominal pain without reason or at night, pain increase after feeding,early satiety, weight loss without reason, recurrent vomiting, iron deficiency anemia without reason 2- Helicobacter pylori infection documented by pathology or rapid urease test 3- Age below 14 and above 2 years Exclusion criteria: 1- Drug consumption including proton pomp inhibitor, histamine blockers, bismuth containing drugs and antibiotics during last 4 weeks 2- History of gastric surgery 3- Hypersensitivity to antibiotics 4-Previous known underlying diseases including renal failure or endocrine diseases

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication. Timepoint: Before intervention and 2 months after intervention (1 month after cessation of treatment). Method of measurement: Pathology or rapid urease test (Baharafshan Co.) on the specimen taken during endoscopy before treatment and fecal antigen test of Helicobacter pylori (G.E.N.E.S.I.S , UK) after treatment.

Secondary

MeasureTime frame
Treatment Side Effects. Timepoint: 2 Weeks After Beginning of Treatment. Method of measurement: Questionnaire.;Endoscopic presentations of Helicobacter pylori. Timepoint: Before intervention. Method of measurement: Endoscopic view recorded in questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasood Unesian

Tehran University of Medical Sciences

chmc@tums.ac.ir+98 21 8896 2510

Outcome results

None listed

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