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Completed

NCT Number: NCT07086937

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziauddin University Hospital

Karachi, Sindh, 74700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitazoxanide

Drug

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

Metronidazole

Drug

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

PPI

Drug

Children were given omeprazole for 14 days.

Clarithromycin

Drug

Children were given clarithromycin for 14 days.

Primary outcomes

  1. Treatment efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

To Compare the Efficacy of Nitrazoxinide Based Triple Therapy Versus Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children at a Tertiary Care Hospital

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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