Helicobacter PyloriPhase 4NILENCT05184491
Nitazoxanide and Lansoprazole Based Regimens for H. Pylori Management
A Phase 4 study testing Naïve patients - ACO therapy, Naïve patients - LNDL therapy and Naïve patients - MNDL therapy in people with Helicobacter Pylori, run by National Liver Institute, Egypt at 1 site in Egypt.
Trial summary
The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Naïve patients - ACO therapy, Naïve patients - LNDL therapy and Naïve patients - MNDL therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 15 Mar 2022
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presented with dyspepsia for more than one month with positive H. pylori antigen test in stool
Who cannot join
- Treatment with proton pump inhibitors, bismuth, H2 receptor antagonist, or sucralfate within the two weeks before study entry, recent use of antibiotics (within one month), allergy to any of the study drugs, active bleeding, gastric surgery, pregnancy, any current malignancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Liver institute - Menoufia University
Shibīn al Kawm, Menoufia
Gasser Elazab, M.D., 01280250026, g.elazab@gmail.com
Ibrahim Eldemshehy, M.S., 01013334106, brahim.eldemshehy@gmail.com
About this study
Official title: Nitazoxanide and Lansoprazole Based Regimens for Managing Helicobacter Pylori in Egyptian Patients (NILE Study)
The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies.
Read the detailed description
This will be randomized, parallel group, comparative open-label study that will be conducted to evaluate the efficacy and tolerability of a four-drug regimen (modified LOAD regimen) in eradicating HP. The study will evaluate the efficacy of modified LOAD regimens(levofloxacin/moxifloxacin, nitazoxanide, doxycycline and lansoprazole) inpatients who failed previous therapies and compare these regimens with the classic triple therapy (amoxicillin, clarithromycin and lansoprazole) in treatment naïve patients.
- Conditions
- Helicobacter Pylori
- Being tested
- Naïve patients - ACO therapy, Naïve patients - LNDL therapy, Naïve patients - MNDL therapy, Treatment-experienced patients- LNDL therapy, Treatment-experienced patients- MNDL therapy
- Keywords
- Helicobacter pylori, Eradication, nitazoxanide, Lansoprazole, LOAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naïve patients - ACO therapyDrug
Naïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days
Naïve patients - LNDL therapyDrug
Naïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
Naïve patients - MNDL therapyDrug
Naïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
Treatment-experienced patients- LNDL therapyDrug
Experienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
Treatment-experienced patients- MNDL therapyDrug
Experienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Naïve patients - ACO therapy | Active comparator | One hundred patients naive to H. Pylori eradication therapy will receive ACO therapy for 14 days (amoxicillin 1 g with breakfast and dinner, clarithromycin 500 mg with breakfast and dinner and lansoprazole 40 mg twice daily before meals). Receives: Drug: Naïve patients - ACO therapy |
| Naïve patients - LNDL therapy | Experimental | One hundred patients naive to H. Pylori eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) Receives: Drug: Naïve patients - LNDL therapy |
| Naïve patients - MNDL therapy | Experimental | One hundred patients naive to H. Pylori eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) Receives: Drug: Naïve patients - MNDL therapy |
| Treatment-experienced patients- LNDL therapy | Experimental | One hundred patients who were unresponsive to previous eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) Receives: Drug: Treatment-experienced patients- LNDL therapy |
| Treatment-experienced patients- MNDL therapy | Experimental | One hundred patients who were unresponsive to previous eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) Receives: Drug: Treatment-experienced patients- MNDL therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA).
successful eradication of H. pylori confirmed by H. pylori antigen test in stool. Monocent, Inc.'s H. pylori Antigen Test System is an enzyme immunoassay for the qualitative and quantitative detection of H. pylori antigen in human stool. The patient has to be asked to collect the specimen avoiding any possible contact with urine or water. The patient submitted to the test should not be under antibiotic or anti-acid treatments.
immunoassay for the qualitative and quantitative detection of H. li tiihtlIt iitdd id ithiy fthqlitti pylori antigen in human stool. diif iblHli
Measured: 4 weeks after completion of treatment
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria
Safety and tolerability of these regimens will be assessed by reporting adverse events by Individual Case Safety Reports for EPVC
Measured: Through study completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Oct 2021
- Primary completion1 Feb 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter PyloriStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Liver Institute, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Future pharmaceutical industries
- Responsible party
- Principal investigator, Gasser Ibrahim El-Azab, National Liver Institute, Egypt
- Investigators
- Gasser El-Azab, M.D., Principal investigator, National Liver Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184491
- Sponsor's protocol ID
- 01013334106
- Acronym
- NILE
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Azab G, Salam SA, Moustafa E, Abuoelhassan A, Shamseya A, Ellakany A, Abdelaal U, Assem M, Khalil F, Mahmoud A, Elsabaawy M, Hussein B, Ezz-Eldin M, Hassany S, Zaghloul N, Magdy M. Levofloxacin versus moxifloxacin in nitazoxanide-based quadruple therapy as a first-line treatment for Helicobacter pylori infection: NILE, a randomized, comparative, multicenter study. Sci Rep. 2026 May 18;16(1):15337. doi: 10.1038/s41598-026-51062-4.
PubMed 42151286
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitazoxanide and Lansoprazole Based Regimens for Managing Helicobacter Pylori in Egyptian Patients (NILE Study)
- ClinicalTrials.gov ID
- NCT05184491
- Acronym / sponsor ID
- NILE / 01013334106
- Conditions
- Helicobacter Pylori
- Keywords
- Helicobacter pylori, Eradication, nitazoxanide, Lansoprazole, LOAD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Liver Institute, EgyptUniversity, hospital or other
- Collaborators
- Future pharmaceutical industries
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies.
Detailed description
This will be randomized, parallel group, comparative open-label study that will be conducted to evaluate the efficacy and tolerability of a four-drug regimen (modified LOAD regimen) in eradicating HP. The study will evaluate the efficacy of modified LOAD regimens(levofloxacin/moxifloxacin, nitazoxanide, doxycycline and lansoprazole) inpatients who failed previous therapies and compare these regimens with the classic triple therapy (amoxicillin, clarithromycin and lansoprazole) in treatment naïve patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Naïve patients - ACO therapy | Active comparator | Drug: Naïve patients - ACO therapyOne hundred patients naive to H. Pylori eradication therapy will receive ACO therapy for 14 days (amoxicillin 1 g with breakfast and dinner, clarithromycin 500 mg with breakfast and dinner and lansoprazole 40 mg twice daily before meals). |
| Naïve patients - LNDL therapy | Experimental | Drug: Naïve patients - LNDL therapyOne hundred patients naive to H. Pylori eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) |
| Naïve patients - MNDL therapy | Experimental | Drug: Naïve patients - MNDL therapyOne hundred patients naive to H. Pylori eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) |
| Treatment-experienced patients- LNDL therapy | Experimental | Drug: Treatment-experienced patients- LNDL therapyOne hundred patients who were unresponsive to previous eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) |
| Treatment-experienced patients- MNDL therapy | Experimental | Drug: Treatment-experienced patients- MNDL therapyOne hundred patients who were unresponsive to previous eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presented with dyspepsia for more than one month with positive H. pylori antigen test in stool
Key exclusion criteria (1 listed)
- Treatment with proton pump inhibitors, bismuth, H2 receptor antagonist, or sucralfate within the two weeks before study entry, recent use of antibiotics (within one month), allergy to any of the study drugs, active bleeding, gastric surgery, pregnancy, any current malignancy.
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 |
|---|---|---|
| Naïve patients - ACO therapyNaïve patients will receive classic triple therapy (amoxicillin, clarithromycin and lansoprazole) for 14 days | Drug | Naïve patients - ACO therapy |
| Naïve patients - LNDL therapyNaïve patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days | Drug | Naïve patients - LNDL therapy |
| Naïve patients - MNDL therapyNaïve patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days | Drug | Naïve patients - MNDL therapy |
| Treatment-experienced patients- LNDL therapyExperienced patients will receive Levofloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days | Drug | Treatment-experienced patients- LNDL therapy |
| Treatment-experienced patients- MNDL therapyExperienced patients will receive Moxifloxacin, nitazoxanide, doxycycline and Lansoprazole for 14 days | Drug | Treatment-experienced patients- MNDL therapy |
Primary outcome
Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA).
Time frame: 4 weeks after completion of treatment
successful eradication of H. pylori confirmed by H. pylori antigen test in stool. Monocent, Inc.'s H. pylori Antigen Test System is an enzyme immunoassay for the qualitative and quantitative detection of H. pylori antigen in human stool. The patient has to be asked to collect the specimen avoiding any possible contact with urine or water. The patient submitted to the test should not be under antibiotic or anti-acid treatments. immunoassay for the qualitative and quantitative detection of H. li tiihtlIt iitdd id ithiy fthqlitti pylori antigen in human stool. diif iblHli
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria
Time frame: Through study completion, an average of 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 42151286El-Azab G, Salam SA, Moustafa E, Abuoelhassan A, Shamseya A, Ellakany A, Abdelaal U, Assem M, Khalil F, Mahmoud A, Elsabaawy M, Hussein B, Ezz-Eldin M, Hassany S, Zaghloul N, Magdy M. Levofloxacin versus moxifloxacin in nitazoxanide-based quadruple therapy as a first-line treatment for Helicobacter pylori infection: NILE, a randomized, comparative, multicenter study. Sci Rep. 2026 May 18;16(1):15337. doi: 10.1038/s41598-026-51062-4.
- 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. This study is not recruiting at the moment.
Gasser El-Azab, M.D. principal investigator
National Liver Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naïve patients - ACO therapy, Naïve patients - LNDL therapy and Naïve patients - MNDL therapy in people with Helicobacter Pylori, run by National Liver Institute, Egypt 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gasser I El-Azab, M.D. (01280250026, g.elazab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA). (time frame: 4 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184491, which also lists 1 linked publication.
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 11 Jan 2022.