H.Pylori InfectionNCT04550858
h.Pylori Ttt With Rebamipide
An observational study of H.Pylori Infection, run by Assiut University.
Trial summary
the primary aim is specially in resistant cases of H.pylori and in promotion of peptic ulcer Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- H.Pylori Infection
- What is being tested?
- Rebamipide
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2020to 21 Sep 2021
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patient with h.pylori infection from assiut university hospital
Who may be able to join
- 20 years of age or older,
- ulcer size, 5 mm or more in longest diameter,
- single ulcer,
- H. pylori positively.
Who cannot join
- use of medications such as PPIs, H2-receptor antagonists, other gastroprotective drugs, or nonsteroidal anti-inflammatory drugs within a week prior to the start of the trial, (2) previous eradication therapy for H. pylori, (3) acute or duodenal ulcer, (4) gastric ulcer with high risk of massive bleeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Treatment With REbamipide for Helicobacter Pylori Eradication Therapy
the primary aim is specially in resistant cases of H.pylori and in promotion of peptic ulcer
Read the detailed description
Helicobacter pylori infection is the main cause of peptic ulcer (1, 2) Some consensus conferences have recommended triple therapy with a proton pump inhibitor (PPI) and two types of antibiotics for 7 days as first-line treatment when patients with peptic ulcer have Helicobacter pylori infection.(3, 4)This recommendation is based on the finding that patients with proven eradication of H. pylori have an extremely low rate of recurrence of peptic ulcer.(5) Although a well-controlled study found comparable rates of small gastric ulcer healing after eradication therapy alone without continuation of antiulcer treatment, relief of symptoms was significantly slower with eradication therapy alone. Moreover, the success rate of eradication therapy has decreased during the past few decades, and whether or not eradication is successful becomes clear only 2-4 weeks after treatment(6).
Patients with large gastric ulcer lesions are often not completely healed with H. pylori eradication alone (7) . Proton pump inhibitors (PPIs) have become the mainstay of maintenance therapy after eradication of H. pylori infection due to the associated effective healing and fast relief of symptoms without tachyphylaxis. However, PPI therapy has some risks, including dyspeptic symptom or rebound acid hypersecretion after cessation that may induce dependence (8,9) , drug interactions with other substrate of CYP2C19, and some kinds of respiratory or gastrointestinal infections . Also, the result of H. pylori eradication can be affected by such antisecretory drugs.(10) Rebamipide is a gastroprotective antiulcer drug that has been found to reduce the rate of recurrence of gastric ulcers without affecting H. pylori status, unlike antisecretory drugs such as PPIs and H2 receptor antagonists.6 and have a healing rate of about 90% at 8 weeks after eradication therapy (11) Rebamipide (2-(4- chlorobenzoylamino)-3-[2-(1H)-quinolinon-4-yl] propionic acid) prevents gastric ulcer formation by inhibiting neutrophil activation. Rebamipide stimulates prostaglandin generation in the gastric mucosa, resulting in stimulation of mucus secretion. Rebamipide inhibits H. pylori adhesion to the gastric epithelial cells.(12) The primary aim of study to evaluate whether rebamipide could improve success rates of anti-H. pylori treatment .
- Conditions
- H.Pylori Infection
- Being tested
- Rebamipide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
rebamipide use for ttt of h.pylori infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric ulcer healing rate in resistant cases of H. pylori resistant cases of h.pylori
healing rate of gastric ulcer defined as complete disappearance of the white coating
Measured: 8 weeks
Secondary outcomes (1)
Eradication of H. pylori
- pylori status will be measured by culture testing and 13C-urea breath test . when both tests are negative H.pylori eradication will be considered successful
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start5 Sep 2020 (estimated)
- Primary completion21 Aug 2021 (estimated)
- Study completion21 Sep 2021 (estimated)
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.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Mohamed Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550858
- Sponsor's protocol ID
- ttt h.pylori with rebamipide
- Status last verified
- Sep 2020
- First submitted
- 21 Aug 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment With REbamipide for Helicobacter Pylori Eradication Therapy
- ClinicalTrials.gov ID
- NCT04550858
- Acronym / sponsor ID
- ttt h.pylori with rebamipide
- Conditions
- H.Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Sep 2020 (estimated)
- Primary completion
- 21 Aug 2021 (estimated)
- Study completion
- 21 Sep 2021 (estimated)
- First posted
- 16 Sep 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 primary aim is specially in resistant cases of H.pylori and in promotion of peptic ulcer
Detailed description
Helicobacter pylori infection is the main cause of peptic ulcer (1, 2) Some consensus conferences have recommended triple therapy with a proton pump inhibitor (PPI) and two types of antibiotics for 7 days as first-line treatment when patients with peptic ulcer have Helicobacter pylori infection.(3, 4)This recommendation is based on the finding that patients with proven eradication of H. pylori have an extremely low rate of recurrence of peptic ulcer.(5) Although a well-controlled study found comparable rates of small gastric ulcer healing after eradication therapy alone without continuation of antiulcer treatment, relief of symptoms was significantly slower with eradication therapy alone. Moreover, the success rate of eradication therapy has decreased during the past few decades, and whether or not eradication is successful becomes clear only 2-4 weeks after treatment(6).
Patients with large gastric ulcer lesions are often not completely healed with H. pylori eradication alone (7) . Proton pump inhibitors (PPIs) have become the mainstay of maintenance therapy after eradication of H. pylori infection due to the associated effective healing and fast relief of symptoms without tachyphylaxis. However, PPI therapy has some risks, including dyspeptic symptom or rebound acid hypersecretion after cessation that may induce dependence (8,9) , drug interactions with other substrate of CYP2C19, and some kinds of respiratory or gastrointestinal infections . Also, the result of H. pylori eradication can be affected by such antisecretory drugs.(10) Rebamipide is a gastroprotective antiulcer drug that has been found to reduce the rate of recurrence of gastric ulcers without affecting H. pylori status, unlike antisecretory drugs such as PPIs and H2 receptor antagonists.6 and have a healing rate of about 90% at 8 weeks after eradication therapy (11) Rebamipide (2-(4- chlorobenzoylamino)-3-[2-(1H)-quinolinon-4-yl] propionic acid) prevents gastric ulcer formation by inhibiting neutrophil activation. Rebamipide stimulates prostaglandin generation in the gastric mucosa, resulting in stimulation of mucus secretion. Rebamipide inhibits H. pylori adhesion to the gastric epithelial cells.(12) The primary aim of study to evaluate whether rebamipide could improve success rates of anti-H. pylori treatment .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patient with h.pylori infection from assiut university hospital
Key inclusion criteria (4 listed)
- 20 years of age or older,
- ulcer size, 5 mm or more in longest diameter,
- single ulcer,
- H. pylori positively.
Key exclusion criteria (1 listed)
- use of medications such as PPIs, H2-receptor antagonists, other gastroprotective drugs, or nonsteroidal anti-inflammatory drugs within a week prior to the start of the trial, (2) previous eradication therapy for H. pylori, (3) acute or duodenal ulcer, (4) gastric ulcer with high risk of massive bleeding
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 |
|---|---|---|
| Rebamipiderebamipide use for ttt of h.pylori infection | Drug | – |
Primary outcome
Gastric ulcer healing rate in resistant cases of H. pylori resistant cases of h.pylori
Time frame: 8 weeks
healing rate of gastric ulcer defined as complete disappearance of the white coating
1 secondary outcome
Eradication of H. pylori
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of H.Pylori Infection, run by Assiut University.
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 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa ahmed abdelrahman (00201201777557, m.hazem75@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric ulcer healing rate in resistant cases of H. pylori resistant cases of h.pylori (time frame: 8 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 16 Sep 2020.