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H.Pylori InfectionNCT04550858

h.Pylori Ttt With Rebamipide

An observational study of H.Pylori Infection, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

marwa ahmed abdelrahman contact

00201201777557

m.hazem75@icloud.com

zain elabdeen sayed, professur contact

00201115596820

zainsayed@aun.edu.eg

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 .

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.

  1. 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)
  1. Eradication of H. pylori

    1. 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.

  1. First posted16 Sep 2020
  2. Study start5 Sep 2020 (estimated)
  3. Primary completion21 Aug 2021 (estimated)
  4. Study completion21 Sep 2021 (estimated)

Resources

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)
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

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.

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