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
0.8
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:
Drug: Clarithromycin
Klacid twice daily
Other Names:
Drug: Proton pump inhibitor
Omeprazoe twice daily
|
Active Comparator: Traditional group Clarithromycin, Metronidazole and Proton pump inhibitor |
Drug: Clarithromycin
Klacid twice daily
Other Names:
Drug: Metronidazole
Metronidazole twice daily
Other Names:
Drug: Proton pump inhibitor
Omeprazoe twice daily
|
Outcome Measures
Primary Outcome Measures
- 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: