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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07086937
Enrollment
66
Registered
2025-07-25
Start date
2025-01-01
Completion date
2025-06-30
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

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.

Interventions

DRUGNitazoxanide

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

DRUGMetronidazole

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

DRUGPPI

Children were given omeprazole for 14 days.

DRUGClarithromycin

Children were given clarithromycin for 14 days.

Sponsors

Muhammad Aamir Latif
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment efficacy6 weeksThe 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.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026