A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

H. Pylori Infection Clinical Trial

Official title:

A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06050824
• Other study ID #: ENDM0003
• Status: Completed
• Phase: Phase 4
• Start date: July 21, 2022
• Est. completion date: July 19, 2023

Study information

• Verified date: September 2023
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.

The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.

About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.

All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.

Biopsies will be classified using the Updated Sydney system of classification of gastritis

Description:

The patients will be randomized (closed envelopes) into one of two groups:

1. patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.

2. patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.

H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients who presented with epigastric pain and dyspeptic symptoms

Exclusion Criteria:

1. Patients recently (within 6 months) treated with anti-H. pylori therapy.

2. Allergy to any drugs used in our protocol

3. Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.

4. Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).

5. Presence of GI malignancy.

6. Pregnancy or lactating women.

7. Unable or refuse to give consent. -

Related Conditions & MeSH terms

• Communicable Diseases
• H. Pylori Infection
• Infections

Intervention

Drug:
• Comparing Load and Concomitant therapy
Levofloxacin - Omeprazole - nitazoxanide - doxycycline

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Helwan University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of H. pylori infection after treatment	Negative stool antigen test for H.pylori	4 weeks after end of treatment