Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children

NCT ID: NCT04415983

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2030-12-01

Brief Summary

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

Detailed Description

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

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nitazoxanide group

Clarithromycin, Nitazoxanide and Proton pump inhibitor

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

Nitazoxanide twice daily

Clarithromycin

Intervention Type DRUG

Klacid twice daily

Proton pump inhibitor

Intervention Type DRUG

Omeprazoe twice daily

Traditional group

Clarithromycin, Metronidazole and Proton pump inhibitor

Group Type ACTIVE_COMPARATOR

Clarithromycin

Intervention Type DRUG

Klacid twice daily

Metronidazole

Intervention Type DRUG

Metronidazole twice daily

Proton pump inhibitor

Intervention Type DRUG

Omeprazoe twice daily

Interventions

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Nitazoxanide

Nitazoxanide twice daily

Intervention Type DRUG

Clarithromycin

Klacid twice daily

Intervention Type DRUG

Metronidazole

Metronidazole twice daily

Intervention Type DRUG

Proton pump inhibitor

Omeprazoe twice daily

Intervention Type DRUG

Other Intervention Names

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nanazoxid Klacid Flagyl

Eligibility Criteria

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Inclusion Criteria

\- Positive helicobacter infection.

Exclusion Criteria

* Previous treatment for H. Pylori.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasha Gamal, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Pediatrics department - Tanta University

sherief Abd-Elsalam, ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Tanta University Faculty of medicine

Abeer Salamah, Lecturer

Role: STUDY_DIRECTOR

Pediatrics department - Kafr Elsheikh University

dina shawky, lecturer

Role: STUDY_DIRECTOR

Pediatrics department - Tanta University

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam, Ass. Prof.

Role: primary

00201009221243

Other Identifiers

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helicobacter children

Identifier Type: -

Identifier Source: org_study_id

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