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

NCT07086937 | Completed

• 1 other identifier: Dr-Shumaila-ZUH
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

  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.

  6 weeks

Study Arms (2)

NTZ-based group

EXPERIMENTAL

Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days.

Drug: Nitazoxanide; Drug: PPI; Drug: Clarithromycin

MTZ-based group

EXPERIMENTAL

Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days.

Drug: Metronidazole; Drug: PPI; Drug: Clarithromycin

Interventions

Nitazoxanide DRUG

Children were given nitazoxanide, PPI, and clarithromycin for 14 days.

NTZ-based group

Metronidazole DRUG

Children received MTZ, PPI, and clarithromycin for 14 days.

MTZ-based group

PPI DRUG

Children were given omeprazole for 14 days.

MTZ-based group; NTZ-based group

Clarithromycin DRUG

Children were given clarithromycin for 14 days.

MTZ-based group; NTZ-based group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Ziauddin University Hospital

Karachi, Sindh, 74700, Pakistan

Location

MeSH Terms

Interventions

nitazoxanide; Metronidazole; Clarithromycin

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Shumaila Waseem

  Ziauddin University Karachi

  PRINCIPAL INVESTIGATOR

• Heena Raees, FCPS

  Ziauddin University Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)