Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

June 1, 2020 updated by: Sherief Abd-Elsalam, Tanta University

Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children

Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter pylori in children

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Positive helicobacter infection.

Exclusion Criteria:

  • Previous treatment for H. Pylori.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nitazoxanide group
Clarithromycin, Nitazoxanide and Proton pump inhibitor
Drug: Nitazoxanide
Nitazoxanide twice daily
Other Names:
  • nanazoxid
Drug: Clarithromycin
Klacid twice daily
Other Names:
  • Klacid
Drug: Proton pump inhibitor
Omeprazoe twice daily
Active Comparator: Traditional group
Clarithromycin, Metronidazole and Proton pump inhibitor
Drug: Clarithromycin
Klacid twice daily
Other Names:
  • Klacid
Drug: Proton pump inhibitor
Omeprazoe twice daily
Drug: Metronidazole
Metronidazole twice daily
Other Names:
  • Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with cured helicobacter infection
Time Frame: 6 months
Total number of patients with eradicated helicobacter infection
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Sherief Abd-Elsalam, ass. prof., Tanta University Faculty of medicine
  • Principal Investigator: Rasha Gamal, Ass. Prof., Pediatrics department - Tanta University
  • Study Director: Abeer Salamah, Lecturer, Pediatrics department - Kafr Elsheikh University
  • Study Director: dina shawky, lecturer, Pediatrics department - Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

October 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • helicobacter children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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