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

Primary Purpose

H. Pylori Infection

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Comparing Load and Concomitant therapy

About this trial

This is an interventional treatment trial for H. Pylori Infection

Eligibility Criteria

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Inclusion Criteria: All patients who presented with epigastric pain and dyspeptic symptoms Exclusion Criteria: Patients recently (within 6 months) treated with anti-H. pylori therapy. Allergy to any drugs used in our protocol Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization. Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease). Presence of GI malignancy. Pregnancy or lactating women. Unable or refuse to give consent. -

Sites / Locations

Faculty of Medicine, Helwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

concomitant

LOAD

Arm Description

Clarithro -pantoprazole- Metronidazole - Amoxicyllin

Levofloxacin -omeprazole- nitazoxanide- Doxycycline

Outcomes

Primary Outcome Measures

Eradication of H. pylori infection after treatment

Negative stool antigen test for H.pylori

Secondary Outcome Measures

Full Information

NCT ID

NCT06050824

First Posted

September 16, 2023

Last Updated

September 22, 2023

Sponsor

Helwan University

1. Study Identification

Unique Protocol Identification Number

NCT06050824

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

July 21, 2022 (Actual)

Primary Completion Date

July 19, 2023 (Actual)

Study Completion Date

July 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

H. Pylori Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

concomitant

Arm Type

Active Comparator

Arm Description

Clarithro -pantoprazole- Metronidazole - Amoxicyllin

Arm Title

LOAD

Arm Type

Active Comparator

Arm Description

Levofloxacin -omeprazole- nitazoxanide- Doxycycline

Intervention Type

Drug

Intervention Name(s)

Comparing Load and Concomitant therapy

Other Intervention Name(s)

Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin

Intervention Description

Levofloxacin - Omeprazole - nitazoxanide - doxycycline

Primary Outcome Measure Information:

Title

Eradication of H. pylori infection after treatment

Description

Negative stool antigen test for H.pylori

Time Frame

4 weeks after end of treatment

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Faculty of Medicine, Helwan University

City

Cairo

ZIP/Postal Code

11795

Country

Egypt

12. IPD Sharing Statement

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

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