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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NTZ-based group

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

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

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

PPI

Intervention Type DRUG

Children were given omeprazole for 14 days.

Clarithromycin

Intervention Type DRUG

Children were given clarithromycin for 14 days.

MTZ-based group

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

Group Type EXPERIMENTAL

Metronidazole

Intervention Type DRUG

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

PPI

Intervention Type DRUG

Children were given omeprazole for 14 days.

Clarithromycin

Intervention Type DRUG

Children were given clarithromycin for 14 days.

Interventions

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Nitazoxanide

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

Intervention Type DRUG

Metronidazole

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

Intervention Type DRUG

PPI

Children were given omeprazole for 14 days.

Intervention Type DRUG

Clarithromycin

Children were given clarithromycin for 14 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No