Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Nitazoxanide; Drug: Metronidazole; Drug: PPI; Drug: Clarithromycin

• Registration Number: NCT07086937
• Lead Sponsor: Muhammad Aamir Latif

Brief Summary

This study aimed at comparing the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for eradication of Helicobacter pylori infection in children at a tertiary care hospital.

Detailed Description

The findings could guide clinical practice and influence guidelines, improving the management of H. pylori infections in the pediatric population. Not much local data also exists comparing the effectiveness of adding nitazoxanide to the standard triple therapy in children with H. pylori infection. If nitazoxanide-based therapy proves superior, it could reduce the incidence of antibiotic resistance associated with standard triple therapy.

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Any gender
• Aged 2 to 12 years
• With symptoms like abdominal pain, nausea, vomiting, or other related gastrointestinal symptoms
• Diagnosed with H. pylori based on urea breath test

Exclusion Criteria

• Liver cirrhosis
• Renal impairment
• Previous gastric or duodenal surgery or malignancy
• History of receiving H. pylori treatment
• Past 6 weeks history of using antacids, H2 receptor antagonists, anticoagulants, or antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NTZ-based group	Nitazoxanide	Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.
NTZ-based group	PPI	Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.
NTZ-based group	Clarithromycin	Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.
MTZ-based group	Metronidazole	Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.
MTZ-based group	PPI	Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.
MTZ-based group	Clarithromycin	Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.

Primary Outcome Measures

Name	Time	Method
Treatment efficacy	6 weeks	The patients were considered clinically cured if they had a negative H. pylori stool Ag test and were free of symptoms at 6 weeks after starting treatment, or otherwise failure was labeled.

Trial Locations

Locations (1)

Ziauddin University Hospital; 🇵🇰 Karachi, Sindh, Pakistan