Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04415983
Collaborator
(none)
100
1
2
126
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2030
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

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: Metronidazole
    Metronidazole twice daily
    Other Names:
  • Flagyl
  • Drug: Proton pump inhibitor
    Omeprazoe twice daily

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with cured helicobacter infection [6 months]

      Total number of patients with eradicated helicobacter infection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Positive helicobacter infection.
    Exclusion Criteria:
    • Previous treatment for H. Pylori.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • Tanta University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04415983
    Other Study ID Numbers:
    • helicobacter children
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 4, 2020