h.Pylori Ttt With Rebamipide

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

Study Overview

• Status: Unknown
• Conditions: H.Pylori Infection
• Intervention / Treatment: Drug: Rebamipide

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient with h.pylori infection from assiut university hospital

Description

Inclusion Criteria:

1. 20 years of age or older,
2. ulcer size, 5 mm or more in longest diameter,
3. single ulcer,
4. H. pylori positively.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication of H. pylori	H. 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	8 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 5, 2020
• Primary Completion (Anticipated): August 21, 2021
• Study Completion (Anticipated): September 21, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Rebamipide
• Other Study ID Numbers: ttt h.pylori with rebamipide

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No