Helicobacter Pylori InfectionPhase 4NCT04445948
Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy
A Phase 4 study testing Esomeprazole 40 milligrams Oral Tablet, Amoxicillin 1000 milligrams tablets and Clarithromycin 500 milligrams Tablets in people with Helicobacter Pylori Infection, run by Alexandria University at 1 site in Egypt.
Trial summary
The investigators aim at evaluating the efficacy of bovine lactoferrin addition to H. Pylori eradication regimens. 400 randomly distributed participants will be assigned to one of four treatment regimens of H. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole 40 milligrams Oral Tablet, Amoxicillin 1000 milligrams tablets and Clarithromycin 500 milligrams Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2019to 21 Jun 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 18-60 years,
- Positive H. Pylori test (Stool antigen / or rapid urease test)
Who cannot join
- The use of proton pump inhibitor , H2-receptor antagonist, bismuth preparation and antibiotics at least 2 weeks before enrollment,
- prior eradication treatment,
- History of gastrectomy,
- Equivocal H. pylori stool antigen (HpSAg) results,
- Severe hepatic (Child Pugh class B or C) or renal diseases (eGFR < 60 ml/min/1.73 m^2),
- Any form of malignancy,
- Proven allergy to clarithromycin, or Penicillin,
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study the Efficacy of Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy in Egyptian Patients
The investigators aim at evaluating the efficacy of bovine lactoferrin addition to H. Pylori eradication regimens. 400 randomly distributed participants will be assigned to one of four treatment regimens of H. Pylori (standard triple therapy, standard triple therapy plus bovine lactoferrin, sequential therapy, or sequential therapy plus bovine lactoferrin), and eradication rates will be evaluated among the four groups.
Read the detailed description
the study included 400 patients recruited from Gastroenterology as well as general internal medicine clinic at Internal Medicine department, Faculty of Medicine, University of Alexandria, Egypt. After initial evaluation, every participant was randomly assigned to one of four equal treatment regimens (using simple randomization, 100 patients for each regimen) All included participant subjected to evaluation as regards demographic parameters, current status of smoking, history of dyspepsia, epigastric pain, heartburn, melena, hematemesis, nauseas / vomiting, weight loss, and dysphagia.
The diagnosis of H. Pylori infection was based on positivity of H. Pylori stool antigen (HpSAg) in patients who were not indicated for upper endoscopic study / or rapid urease test during esophagogastroduodenoscopy (EGD).
The HpSAg enzyme-linked immunoassay was read spectrophotometrically at 450 nm and the results are recorded as negative if the optical density (O.D.) is <0.14, positive if O.D. ≥0.16, and equivocal for any values ≥0.14 and <0.16.
Upper endoscopy was done to all patients above 45 years of age or patients with alarming symptoms (melena, hematemesis, weight loss, and dysphagia) or family history of gastric cancer.
Rapid urease test was done during EGD as an invasive tool for diagnosis of H.Pylori infection.
After diagnosis, patients were randomly assigned as following:
group (A) received the triple therapy for 2 weeks in the form of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily and clarithromycin 500 milligrams twice daily after meal; group (B) received the sequential therapy in the form of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily for 5 days and then esomeprazole 40 milligrams once daily 30 minutes before breakfast plus metronidazole 500 milligrams twice daily and clarithromycin 500 milligrams twice daily after meal for 10 days; group (C) received the triple therapy for 2 weeks in addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30 minutes after breakfast and dinner for 14 days; group (D) received the sequential therapy in addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30 minutes after breakfast and dinner for 14 days.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole 40 milligrams Oral Tablet, Amoxicillin 1000 milligrams tablets, Clarithromycin 500 milligrams Tablets, MetroNIDAZOLE 500 milligrams Oral Tablet, Lactoferrin Bovine sachets 200 milligrams
- Keywords
- H.pylori; Lactoferrin; triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40 milligrams Oral TabletDrug
Also called Nexium, Esompex
Proton Pump inhibitor
Amoxicillin 1000 milligrams tabletsDrug
Also called Amoxil, Amoxicillin
Penicillin derivative antibiotic
Clarithromycin 500 milligrams TabletsDrug
Also called Klacid, Klarithro
Macrolide antibiotic
MetroNIDAZOLE 500 milligrams Oral TabletDrug
Also called Amrizole, Flagyle
Antiprotozoal
Lactoferrin Bovine sachets 200 milligramsDrug
Also called Pravotin
a protein found naturally in milk from humans and cows
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy | Active comparator | Received triple therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 gram tablets twice daily and clarithromycin 500 milligrams tablets twice daily after meal for 14 days. Receives: Drug: Esomeprazole 40 milligrams Oral Tablet; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets |
| Sequential Therapy | Active comparator | Received the sequential therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 g tablets twice daily for 5 days, then esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus metronidazole 500 milligrams tablets twice daily plus clarithromycin 500 milligrams tablets twice daily after meal for another 10 days. Receives: Drug: Esomeprazole 40 milligrams Oral Tablet; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet |
| Triple Therapy plus Lactoferrin | Active comparator | Received triple therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 gram tablets twice daily and clarithromycin 500 milligrams tablets twice daily after meal for 14 days. in addition to 200 milligrams of bovine lactoferrin sachets twice daily 30 minutes after breakfast and dinner for 14 days. Receives: Drug: Esomeprazole 40 milligrams Oral Tablet; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets; Drug: Lactoferrin Bovine sachets 200 milligrams |
| Sequential Therapy plus Lactoferrin | Active comparator | Received the sequential therapy in the form of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily for 5 days, then esomeprazole 40 mg once daily 30 minutes before breakfast plus metronidazole 500 milligrams twice daily plus clarithromycin 500 milligrams twice daily after meal for another 10 days in addition to 200 milligrams of bovine lactoferrin sachets twice daily 30 minutes after breakfast and dinner throughout the 15 days. Receives: Drug: Esomeprazole 40 milligrams Oral Tablet; Drug: Amoxicillin 1000 milligrams tablets; Drug: Clarithromycin 500 milligrams Tablets; Drug: MetroNIDAZOLE 500 milligrams Oral Tablet; Drug: Lactoferrin Bovine sachets 200 milligrams |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. Pylori eradication rate
- Pylori eradication rate among the four groups as evaluated by negativity of H. Pylori stool antigen
Measured: evaluated 28 days after last dose of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start30 Nov 2019
- Primary completion21 Jun 2020
- Study completion21 Jun 2020
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 Alexandria 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alexandria
- Responsible party
- Principal investigator, Sameh A. Lashen, Alexandria University
- Investigators
- Sameh A Lashen, MD(PhD), Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445948
- Sponsor's protocol ID
- 0304432
- Status last verified
- Jun 2020
- First submitted
- 21 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data confidentiality will be preserved
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Efficacy of Lactoferrin in Helicobacter Pylori Eradication Either With Standard Triple Therapy or Sequential Therapy in Egyptian Patients
- ClinicalTrials.gov ID
- NCT04445948
- Acronym / sponsor ID
- 0304432
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H.pylori; Lactoferrin; triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- University of Alexandria
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 21 Jun 2020 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 24 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.
The investigators aim at evaluating the efficacy of bovine lactoferrin addition to H. Pylori eradication regimens. 400 randomly distributed participants will be assigned to one of four treatment regimens of H. Pylori (standard triple therapy, standard triple therapy plus bovine lactoferrin, sequential therapy, or sequential therapy plus bovine lactoferrin), and eradication rates will be evaluated among the four groups.
Detailed description
the study included 400 patients recruited from Gastroenterology as well as general internal medicine clinic at Internal Medicine department, Faculty of Medicine, University of Alexandria, Egypt. After initial evaluation, every participant was randomly assigned to one of four equal treatment regimens (using simple randomization, 100 patients for each regimen) All included participant subjected to evaluation as regards demographic parameters, current status of smoking, history of dyspepsia, epigastric pain, heartburn, melena, hematemesis, nauseas / vomiting, weight loss, and dysphagia.
The diagnosis of H. Pylori infection was based on positivity of H. Pylori stool antigen (HpSAg) in patients who were not indicated for upper endoscopic study / or rapid urease test during esophagogastroduodenoscopy (EGD).
The HpSAg enzyme-linked immunoassay was read spectrophotometrically at 450 nm and the results are recorded as negative if the optical density (O.D.) is <0.14, positive if O.D. ≥0.16, and equivocal for any values ≥0.14 and <0.16.
Upper endoscopy was done to all patients above 45 years of age or patients with alarming symptoms (melena, hematemesis, weight loss, and dysphagia) or family history of gastric cancer.
Rapid urease test was done during EGD as an invasive tool for diagnosis of H.Pylori infection.
After diagnosis, patients were randomly assigned as following:
group (A) received the triple therapy for 2 weeks in the form of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily and clarithromycin 500 milligrams twice daily after meal; group (B) received the sequential therapy in the form of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily for 5 days and then esomeprazole 40 milligrams once daily 30 minutes before breakfast plus metronidazole 500 milligrams twice daily and clarithromycin 500 milligrams twice daily after meal for 10 days; group (C) received the triple therapy for 2 weeks in addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30 minutes after breakfast and dinner for 14 days; group (D) received the sequential therapy in addition to 200 milligrams of commercially available bovine lactoferrin twice daily 30 minutes after breakfast and dinner for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy | Active comparator | Drug: Esomeprazole 40 milligrams Oral Tablet, Drug: Amoxicillin 1000 milligrams tablets, Drug: Clarithromycin 500 milligrams TabletsReceived triple therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 gram tablets twice daily and clarithromycin 500 milligrams tablets twice daily after meal for 14 days. |
| Sequential Therapy | Active comparator | Drug: Esomeprazole 40 milligrams Oral Tablet, Drug: Amoxicillin 1000 milligrams tablets, Drug: Clarithromycin 500 milligrams Tablets, Drug: MetroNIDAZOLE 500 milligrams Oral TabletReceived the sequential therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 g tablets twice daily for 5 days, then esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus metronidazole 500 milligrams tablets twice daily plus clarithromycin 500 milligrams tablets twice daily after meal for another 10 days. |
| Triple Therapy plus Lactoferrin | Active comparator | Drug: Esomeprazole 40 milligrams Oral Tablet, Drug: Amoxicillin 1000 milligrams tablets, Drug: Clarithromycin 500 milligrams Tablets, Drug: Lactoferrin Bovine sachets 200 milligramsReceived triple therapy in the form of esomeprazole 40 milligrams tablets once daily 30 minutes before breakfast plus amoxicillin 1 gram tablets twice daily and clarithromycin 500 milligrams tablets twice daily after meal for 14 days. in addition to 200 milligrams of bovine lactoferrin sachets twice daily 30 minutes after breakfast and dinner for 14 days. |
| Sequential Therapy plus Lactoferrin | Active comparator | Drug: Esomeprazole 40 milligrams Oral Tablet, Drug: Amoxicillin 1000 milligrams tablets, Drug: Clarithromycin 500 milligrams Tablets, Drug: MetroNIDAZOLE 500 milligrams Oral Tablet, Drug: Lactoferrin Bovine sachets 200 milligramsReceived the sequential therapy in the form of esomeprazole 40 milligrams once daily 30 minutes before breakfast plus amoxicillin 1 gram twice daily for 5 days, then esomeprazole 40 mg once daily 30 minutes before breakfast plus metronidazole 500 milligrams twice daily plus clarithromycin 500 milligrams twice daily after meal for another 10 days in addition to 200 milligrams of bovine lactoferrin sachets twice daily 30 minutes after breakfast and dinner throughout the 15 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age group 18-60 years,
- Positive H. Pylori test (Stool antigen / or rapid urease test)
Key exclusion criteria (8 listed)
- The use of proton pump inhibitor , H2-receptor antagonist, bismuth preparation and antibiotics at least 2 weeks before enrollment,
- prior eradication treatment,
- History of gastrectomy,
- Equivocal H. pylori stool antigen (HpSAg) results,
- Severe hepatic (Child Pugh class B or C) or renal diseases (eGFR < 60 ml/min/1.73 m^2),
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 |
|---|---|---|
| Esomeprazole 40 milligrams Oral TabletAlso: Nexium, EsompexProton Pump inhibitor | Drug | Sequential Therapy, Sequential Therapy plus Lactoferrin, Triple Therapy, Triple Therapy plus Lactoferrin |
| Amoxicillin 1000 milligrams tabletsAlso: Amoxil, AmoxicillinPenicillin derivative antibiotic | Drug | Sequential Therapy, Sequential Therapy plus Lactoferrin, Triple Therapy, Triple Therapy plus Lactoferrin |
| Clarithromycin 500 milligrams TabletsAlso: Klacid, KlarithroMacrolide antibiotic | Drug | Sequential Therapy, Sequential Therapy plus Lactoferrin, Triple Therapy, Triple Therapy plus Lactoferrin |
| MetroNIDAZOLE 500 milligrams Oral TabletAlso: Amrizole, FlagyleAntiprotozoal | Drug | Sequential Therapy, Sequential Therapy plus Lactoferrin |
| Lactoferrin Bovine sachets 200 milligramsAlso: Pravotina protein found naturally in milk from humans and cows | Drug | Sequential Therapy plus Lactoferrin, Triple Therapy plus Lactoferrin |
Primary outcome
H. Pylori eradication rate
Time frame: evaluated 28 days after last dose of treatment
H. Pylori eradication rate among the four groups as evaluated by negativity of H. Pylori stool antigen
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 Jun 2020.
- Individual participant dataSharing planned: No. data confidentiality will be preserved
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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.
Sameh A Lashen, MD(PhD) principal investigator
University of Alexandria
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 Esomeprazole 40 milligrams Oral Tablet, Amoxicillin 1000 milligrams tablets and Clarithromycin 500 milligrams Tablets in people with Helicobacter Pylori Infection, run by Alexandria 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 2 inclusion and 8 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 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 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?
H. Pylori eradication rate (time frame: evaluated 28 days after last dose 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 25 Jun 2020.