h.Pylori Ttt With Rebamipide

H.Pylori Infection Clinical Trial

Official title:

Effect of Treatment With REbamipide for Helicobacter Pylori Eradication Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04550858
• Other study ID #: ttt h.pylori with rebamipide
• Status: Not yet recruiting
• Start date: September 5, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: marwa ahmed abdelrahman
• Phone: 00201201777557
• Email: m.hazem75[@]icloud.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

the primary aim is specially in resistant cases of H.pylori and in promotion of peptic ulcer

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 21, 2021
• Est. primary completion date: August 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• H.Pylori Infection

Intervention

Drug:
• Rebamipide
rebamipide use for ttt of h.pylori infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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