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

Muhammad Aamir Latif

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: PPI; Drug: Nitazoxanide; Drug: Clarithromycin; Drug: Metronidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT07086937

Dr-Shumaila-ZUH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

NTZ-based group

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Nitazoxanide

Drug: PPI

MTZ-based group

Experimental group

Description:

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

Treatment:

Drug: Metronidazole

Drug: Clarithromycin

Drug: PPI