Helicobacter Pylori InfectionPhase 3NCT04415983
Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children
A Phase 3 study testing Nitazoxanide, Clarithromycin and Metronidazole in people with Helicobacter Pylori Infection, run by Tanta University at 1 site in Egypt.
Trial summary
Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Nitazoxanide, Clarithromycin and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Positive helicobacter infection.
Who cannot join
- Previous treatment for H. Pylori.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: 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
Read the detailed description
Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter pylori in children
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Nitazoxanide, Clarithromycin, Metronidazole, Proton pump inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called nanazoxid
Nitazoxanide twice daily
ClarithromycinDrug
Also called Klacid
Klacid twice daily
MetronidazoleDrug
Also called Flagyl
Metronidazole twice daily
Proton pump inhibitorDrug
Omeprazoe twice daily
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide group | Experimental | Clarithromycin, Nitazoxanide and Proton pump inhibitor Receives: Drug: Nitazoxanide; Drug: Clarithromycin; Drug: Proton pump inhibitor |
| Traditional group | Active comparator | Clarithromycin, Metronidazole and Proton pump inhibitor Receives: Drug: Clarithromycin; Drug: Metronidazole; Drug: Proton pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with cured helicobacter infection
Total number of patients with eradicated helicobacter infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Rasha Gamal, Ass. Prof., Principal investigator, Pediatrics department - Tanta Universitysherief Abd-Elsalam, ass. Prof., Principal investigator, Tanta University Faculty of medicineAbeer Salamah, Lecturer, Study director, Pediatrics department - Kafr Elsheikh Universitydina shawky, lecturer, Study director, Pediatrics department - Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415983
- Sponsor's protocol ID
- helicobacter children
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children
- ClinicalTrials.gov ID
- NCT04415983
- Acronym / sponsor ID
- helicobacter children
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children
Detailed description
Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter pylori in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide group | Experimental | Drug: Nitazoxanide, Drug: Clarithromycin, Drug: Proton pump inhibitorClarithromycin, Nitazoxanide and Proton pump inhibitor |
| Traditional group | Active comparator | Drug: Clarithromycin, Drug: Metronidazole, Drug: Proton pump inhibitorClarithromycin, Metronidazole and Proton pump inhibitor |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Positive helicobacter infection.
Key exclusion criteria (1 listed)
- Previous treatment for H. Pylori.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: nanazoxidNitazoxanide twice daily | Drug | Nitazoxanide group |
| ClarithromycinAlso: KlacidKlacid twice daily | Drug | Nitazoxanide group, Traditional group |
| MetronidazoleAlso: FlagylMetronidazole twice daily | Drug | Traditional group |
| Proton pump inhibitorOmeprazoe twice daily | Drug | Nitazoxanide group, Traditional group |
Primary outcome
Number of patients with cured helicobacter infection
Time frame: 6 months
Total number of patients with eradicated helicobacter infection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rasha Gamal, Ass. Prof. principal investigator
Pediatrics department - Tanta University
sherief Abd-Elsalam, ass. Prof. principal investigator
Tanta University Faculty of medicine
Abeer Salamah, Lecturer study director
Pediatrics department - Kafr Elsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide, Clarithromycin and Metronidazole in people with Helicobacter Pylori Infection, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with cured helicobacter infection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.