Probiotics in the treatment of Helicobacter Pylori infection

Comparison of the effect of antibiotic with antibiotic and probiotic combination in the eradication of Helicobacter Pylori infection in children by a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201201218793N1

Enrollment

Registered

2012-04-09

Start date

2012-01-21

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

Interventions

Intervention 1: In the intervention group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (

Treatment - Drugs

Placebo

In the intervention group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1

In the control group Amoxicillin (dose 50 mg / kg / day/divided in 2 doses) and Furazolidone (dose of 6 mg / kg / day/divided in 2 doses) for 1 week and Omeprazole for 4 weeks (with a dose of 1 mg /

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: more than 2 and less than 14 years of age; gastrointestinal symptoms including epigastric tenderness, abdominal pain at night, worsening of abdominal pain by eating, early satiety, abdominal pain or weight loss without a known cause, frequent vomiting and Iron deficiency anemia; confirmation of Helicobacter Pylori infection by rapid urease test or histopathology. Exclusion criteria: use of proton pump inhibitors, H2 receptor antagonists, bismuth compounds and antibiotics in the past 4 weeks; history of surgery on the stomach; sensitivity to certain types of antibiotics; G6PD enzyme deficiency(in these patients the use of furazolidone may lead to anemia ); known underlying disease including renal failure, heart disease or endocrine disease.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Eradication rate of helicobacter pylori. Timepoint: after two months of the treatment. Method of measurement: stool antigen for helicobacter pylori.	—

Secondary

Measure	Time frame
Endoscopic finding. Timepoint: at the time of endoscopy. Method of measurement: by the report of the person performing the endoscopy.;Adverse effects of the drugs. Timepoint: during the course of treatment. Method of measurement: subjective /asking the patients and parents.;Concordance of the result of rapid urease test and pathology report. Timepoint: after the pathology report is prepared. Method of measurement: The comparison of the result of urease test with histopathological report by the researchers.	—

Measure

Time frame

Endoscopic finding. Timepoint: at the time of endoscopy. Method of measurement: by the report of the person performing the endoscopy.;Adverse effects of the drugs. Timepoint: during the course of treatment. Method of measurement: subjective /asking the patients and parents.;Concordance of the result of rapid urease test and pathology report. Timepoint: after the pathology report is prepared. Method of measurement: The comparison of the result of urease test with histopathological report by the researchers.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shoaran

Tehran University of Medical Sciences

maryamshoaran@yahoo.com; maryamshoaran1@gmail.com+98 21 6692 4545

Outcome results

None listed

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