MedTrace Logo

Nitazoxanide vs Metronidazole for Entamoeba Diarrhea in Children

NCT07790926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-27

No results posted yet for this study

Summary

This randomized controlled trial is comparing two medicines, nitazoxanide and metronidazole, for the treatment of diarrhea caused by Entamoeba histolytica in children. The study is being conducted in the Department of Pediatric Medicine at The Children's Hospital \& The Institute of Child Health Sciences, Lahore.

A total of 90 children with diarrhea caused by Entamoeba histolytica are included in the study. Participants are randomly assigned to one of two treatment groups. One group receives nitazoxanide, while the other group receives metronidazole. Nitazoxanide is given according to the child's age for 3 days, while metronidazole is given according to body weight for 5 days.

The main purpose of the study is to compare how effective the two medicines are in improving diarrhea. Treatment effectiveness is assessed by reduction in stool frequency to three or fewer stools per day and improvement to normal stool consistency. Participants are also assessed for duration of hospital stay and other clinical characteristics. Stool samples are examined after treatment to assess for the presence of Entamoeba cysts or trophozoites.

The study aims to determine whether nitazoxanide or metronidazole provides better treatment outcomes in children with Entamoeba histolytica diarrhea.

Conditions

  • Entamoeba Histolytica Diarrhea

Interventions

DRUG

Nitazoxanide

Nitazoxanide will be administered orally twice daily for 3 days. Children aged 2-3 years will receive 100 mg per dose, while children aged 4-11 years will receive 200 mg per dose. Treatment will be provided to participants randomized to the nitazoxanide group, with clinical assessment during treatment and follow-up to evaluate treatment efficacy and resolution of diarrhea.

DRUG

Metronidazole

Metronidazole will be administered orally to children diagnosed with Entamoeba histolytica-associated diarrhea. The drug will be given at the recommended pediatric dose according to the child's age and body weight, divided into appropriate daily doses for the prescribed treatment duration. It will serve as the active comparator treatment in the study. Treatment response will be assessed based on clinical improvement, including resolution of diarrhea and other associated symptoms, and compared with the nitazoxanide group.

Sponsors & Collaborators

  • University of Child Health Sciences and Children's Hospital, Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2025-04-01
Completion
2025-04-01

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07790926 on ClinicalTrials.gov