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

NCT06050824 | Completed Phase 4

• 1 other identifier: ENDM0003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication of H. pylori infection after treatment

  Negative stool antigen test for H.pylori

  4 weeks after end of treatment

Study Arms (2)

concomitant

ACTIVE COMPARATOR

Clarithro -pantoprazole- Metronidazole - Amoxicyllin

Drug: Comparing Load and Concomitant therapy

LOAD

ACTIVE COMPARATOR

Levofloxacin -omeprazole- nitazoxanide- Doxycycline

Drug: Comparing Load and Concomitant therapy

Interventions

Comparing Load and Concomitant therapy DRUG

Levofloxacin - Omeprazole - nitazoxanide - doxycycline

Also known as: Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin

LOAD; concomitant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who presented with epigastric pain and dyspeptic symptoms

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Faculty of Medicine, Helwan University

Cairo, 11795, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 22, 2023
• Study Start: July 21, 2022
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

EG (1)