Helicobacter Pylori InfectionNCT07086937
Efficacy of Nitazoxanide Based Therapy vs Standard Triple Therapy in H-pylori in Children
A study testing Nitazoxanide, Metronidazole and PPI in people with Helicobacter Pylori Infection, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
This study aimed at comparing the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for eradication of Helicobacter pylori infection in children at a tertiary care hospital. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Nitazoxanide, Metronidazole and PPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any gender
- Aged 2 to 12 years
- With symptoms like abdominal pain, nausea, vomiting, or other related gastrointestinal symptoms
- Diagnosed with H. pylori based on urea breath test
Who cannot join
- Liver cirrhosis
- Renal impairment
- Previous gastric or duodenal surgery or malignancy
- History of receiving H. pylori treatment
- Past 6 weeks history of using antacids, H2 receptor antagonists, anticoagulants, or antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Efficacy of Nitrazoxinide Based Triple Therapy Versus Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children at a Tertiary Care Hospital
This study aimed at comparing the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for eradication of Helicobacter pylori infection in children at a tertiary care hospital.
Read the detailed description
The findings could guide clinical practice and influence guidelines, improving the management of H. pylori infections in the pediatric population. Not much local data also exists comparing the effectiveness of adding nitazoxanide to the standard triple therapy in children with H. pylori infection. If nitazoxanide-based therapy proves superior, it could reduce the incidence of antibiotic resistance associated with standard triple therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Nitazoxanide, Metronidazole, PPI, Clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Children were given nitazoxanide, PPI, and clarithromycin for 14 days.
MetronidazoleDrug
Children received MTZ, PPI, and clarithromycin for 14 days.
PPIDrug
Children were given omeprazole for 14 days.
ClarithromycinDrug
Children were given clarithromycin for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| NTZ-based group | Experimental | Children in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days. Receives: Drug: Nitazoxanide; Drug: PPI; Drug: Clarithromycin |
| MTZ-based group | Experimental | Children in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days. Receives: Drug: Metronidazole; Drug: PPI; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
The patients were considered clinically cured if they had a negative H. pylori stool Ag test and were free of symptoms at 6 weeks after starting treatment, or otherwise failure was labeled.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Shumaila Waseem, Principal investigator, Ziauddin University KarachiHeena Raees, FCPS, Study director, Ziauddin University Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086937
- Sponsor's protocol ID
- Dr-Shumaila-ZUH
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Efficacy of Nitrazoxinide Based Triple Therapy Versus Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children at a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07086937
- Acronym / sponsor ID
- Dr-Shumaila-ZUH
- Conditions
- Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Jul 2025 (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.
This study aimed at comparing the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for eradication of Helicobacter pylori infection in children at a tertiary care hospital.
Detailed description
The findings could guide clinical practice and influence guidelines, improving the management of H. pylori infections in the pediatric population. Not much local data also exists comparing the effectiveness of adding nitazoxanide to the standard triple therapy in children with H. pylori infection. If nitazoxanide-based therapy proves superior, it could reduce the incidence of antibiotic resistance associated with standard triple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTZ-based group | Experimental | Drug: Nitazoxanide, Drug: PPI, Drug: ClarithromycinChildren in NTZ-based group were given triple regimen, i.e., nitazoxanide, PPI, and clarithromycin for 14 days. |
| MTZ-based group | Experimental | Drug: Metronidazole, Drug: PPI, Drug: ClarithromycinChildren in MTZ-based triple regimen received metronidazole, PPI, and clarithromycin for 14 days. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Any gender
- Aged 2 to 12 years
- With symptoms like abdominal pain, nausea, vomiting, or other related gastrointestinal symptoms
- Diagnosed with H. pylori based on urea breath test
Key exclusion criteria (5 listed)
- Liver cirrhosis
- Renal impairment
- Previous gastric or duodenal surgery or malignancy
- History of receiving H. pylori treatment
- Past 6 weeks history of using antacids, H2 receptor antagonists, anticoagulants, or antibiotics
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 |
|---|---|---|
| NitazoxanideChildren were given nitazoxanide, PPI, and clarithromycin for 14 days. | Drug | NTZ-based group |
| MetronidazoleChildren received MTZ, PPI, and clarithromycin for 14 days. | Drug | MTZ-based group |
| PPIChildren were given omeprazole for 14 days. | Drug | MTZ-based group, NTZ-based group |
| ClarithromycinChildren were given clarithromycin for 14 days. | Drug | MTZ-based group, NTZ-based group |
Primary outcome
Treatment efficacy
Time frame: 6 weeks
The patients were considered clinically cured if they had a negative H. pylori stool Ag test and were free of symptoms at 6 weeks after starting treatment, or otherwise failure was labeled.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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. This study is not recruiting at the moment.
Shumaila Waseem principal investigator
Ziauddin University Karachi
Heena Raees, FCPS study director
Ziauddin University Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitazoxanide, Metronidazole and PPI in people with Helicobacter Pylori Infection, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jul 2025. 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 Pakistan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: 6 weeks). 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 25 Jul 2025.