Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children

H Pylori Gastritis Clinical Trial

— CETR  

Official title:

Comparison of Efficacy and Safety of Triple Regimen Based on Clarithromycin VS Metronidazole in Pediatric Population in Pakistan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721704
• Other study ID #: F-.1-1/2015/ERB/SZABMU/646
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: September 14, 2022

Study information

• Verified date: January 2021
• Source: Shaheed Zulfiqar Ali Bhutto Medical University
• Contact: Nadia Waheed
• Phone: 923334461116
• Email: drnadiasalman[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All children from 1day to 18years of age, diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences, Islamabad, from July 2020 to December 2021 will be included in the study. After informed written consent from parents/ guardians patients' bio data along with history and examination will be recorded on a proforma. They will be allocated into two groups, group A and group B randomly based on treatment regimen offered.

Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI) Group B:

Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI The history will include presenting symptoms along duration, remission of symptoms after therapy and clinical outcome will also be recorded.

Description:

Helicobacter pylori is a gram-negative bacillus responsible for one of the most common infections found in humans worldwide1. In general, the prevalence is high in developing countries and the infection is acquired at a young age. Most children infected with H pylori are asymptomatic. Antral gastritis is the most common manifestation in children. Duodenal and gastric ulcers may be associated with H pylori gastritis in 1.8 % children2. Antibiotic resistance is the major cause of failure in the treatment of H pylori infection3. Most of the studies worldwide confirmed an increase in macrolide resistance, while metronidazole resistance either decreased or remained stable. In a prospective multicenter European study, primarily comprised of adults, found a 31.8% resistance rate to clarithromycin and 25.7% to metronidazole in the study4.

If the strain is resistant to one of the antibiotics used, treatment success will be compromised5. As a result therapies that are recommended should be based on antibiotic susceptibility testing. If this testing is not available, then clarithromycin-based triple therapy should not be used as part of first-line therapy due to high rates of clarithromycin resistance rates6 The European Society for Paeditric Gastroenterology Hepatology and Nutrition/North American Society for Pediatric Gastroenterology, Hepatology and Nutrition made the recommendations in 2017 for the Management of Helicobacter pylori in Children that antimicrobial sensitivity should be obtained for the infecting H pylori to tailor eradication therapy accordingly and the effectiveness of first-line therapy should be evaluated in national/regional centers7.

If the strain is susceptible to clarithromycin (CLA) and to metronidazole (MET), triple therapy (PPI, amoxicillin [AMO], CLA) for 14 days and doses of proton pump inhibitor and antibiotics should be calculated based on the bodyweight8.

We aim to study efficacy and safety of clarithromycin vs metronidazole based triple regimen for the eradication of H pylori in children with peptic ulcer disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 14, 2022
• Est. primary completion date: September 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• 1. All children age 1-12 years having H-pylori gastritis

Exclusion Criteria:

• drug induced gastritis critically ill child

Related Conditions & MeSH terms

• Gastritis
• H Pylori Gastritis

Intervention

Drug:
• Clarithromycin+ Amoxicillin + Omeprazole
In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
• Metronidazole +Amoxicillin + Omeprazole
Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI

Locations

Country	Name	City	State
Pakistan	Pakistan Institute of Medical Sciences, Islamabad	Islamabad	Islamabad Capital Territory
Pakistan	Pakistan Institute of Medical Sciences,SZABMU	Islamabad	Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Clarithromycin vs Metronidazole based triple regimen in treatment of H-pylori in induced Acid peptic disease in children in terms of reduction in duration of symptoms and negative Stool H-Pylori-Ag	All children age 1-12 years diagnosed with acid peptic disease with positive H-pylori Ag in stool will be randomized in to Group A & Group B and will be given either CLA or MET based triple eradication regimen. After 4 weeks of complication of triple regimen patients form both groups will be re-tested for H-pylori Ag in stool. The efficacy of both regimen will be compare in terms of duration of resolution of symptoms of Acid peptic disease and number of patients having negative stool H pylori Ag post treatment.	2 weeks