H. Pylori InfectionPhase 4NCT06050824
A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
A Phase 4 study testing Comparing Load and Concomitant therapy in people with H. Pylori Infection, run by Helwan University at 1 site in Egypt.
Trial summary
All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies. The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography. About 200 patients diagnosed to have H. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Comparing Load and Concomitant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jul 2022to 19 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who presented with epigastric pain and dyspeptic symptoms
Who cannot join
- Patients recently (within 6 months) treated with anti-H. pylori therapy.
- Allergy to any drugs used in our protocol
- Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
- Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
- Presence of GI malignancy.
- Pregnancy or lactating women.
- Unable or refuse to give consent. -
Trial locations and contacts
1 site in 1 country.
About this study
All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.
The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.
Read more
About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.
All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.
Biopsies will be classified using the Updated Sydney system of classification of gastritis
Read the detailed description
The patients will be randomized (closed envelopes) into one of two groups:
- patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
- patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.
- Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.
- Conditions
- H. Pylori Infection
- Being tested
- Comparing Load and Concomitant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing Load and Concomitant therapyDrug
Also called Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin
Levofloxacin - Omeprazole - nitazoxanide - doxycycline
| Study group | Role | What they receive |
|---|---|---|
| concomitant | Active comparator | Clarithro -pantoprazole- Metronidazole - Amoxicyllin Receives: Drug: Comparing Load and Concomitant therapy |
| LOAD | Active comparator | Levofloxacin -omeprazole- nitazoxanide- Doxycycline Receives: Drug: Comparing Load and Concomitant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of H. pylori infection after treatment
Negative stool antigen test for H.pylori
Measured: 4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start21 Jul 2022
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Hany Shehata, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050824
- Sponsor's protocol ID
- ENDM0003
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT06050824
- Acronym / sponsor ID
- ENDM0003
- Conditions
- H. Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 22 Sep 2023 (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.
All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.
The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.
About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.
All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.
Biopsies will be classified using the Updated Sydney system of classification of gastritis
Detailed description
The patients will be randomized (closed envelopes) into one of two groups:
- patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
- patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.
- Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concomitant | Active comparator | Drug: Comparing Load and Concomitant therapyClarithro -pantoprazole- Metronidazole - Amoxicyllin |
| LOAD | Active comparator | Drug: Comparing Load and Concomitant therapyLevofloxacin -omeprazole- nitazoxanide- Doxycycline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who presented with epigastric pain and dyspeptic symptoms
Key exclusion criteria (7 listed)
- Patients recently (within 6 months) treated with anti-H. pylori therapy.
- Allergy to any drugs used in our protocol
- Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
- Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
- Presence of GI 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 |
|---|---|---|
| Comparing Load and Concomitant therapyAlso: Clarithromycin - pantoprazole - Metronidazole - AmoxycyllinLevofloxacin - Omeprazole - nitazoxanide - doxycycline | Drug | LOAD, concomitant |
Primary outcome
Eradication of H. pylori infection after treatment
Time frame: 4 weeks after end of treatment
Negative stool antigen test for H.pylori
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 26 Sep 2023.
Related trials for H. Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Comparing Load and Concomitant therapy in people with H. Pylori Infection, run by Helwan 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 7 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 26 Sep 2023. 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?
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?
Eradication of H. pylori infection after treatment (time frame: 4 weeks after end of treatment). 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 26 Sep 2023.