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

Sponsor
Helwan University (Other)
Overall Status
Completed
CT.gov ID
NCT06050824
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
11.9
Actual Duration (Months)
16.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Comparing Load and Concomitant therapy
 Phase 4

Detailed 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.

  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
Actual Study Start Date :
Jul 21, 2022
Actual Primary Completion Date :
Jul 19, 2023
Actual Study Completion Date :
Jul 19, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: concomitant

Clarithro -pantoprazole- Metronidazole - Amoxicyllin

Drug: Comparing Load and Concomitant therapy
Levofloxacin - Omeprazole - nitazoxanide - doxycycline
Other Names:
  • Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin

    		•
    Active Comparator: LOAD

    Levofloxacin -omeprazole- nitazoxanide- Doxycycline

    Drug: Comparing Load and Concomitant therapy
    Levofloxacin - Omeprazole - nitazoxanide - doxycycline
    Other Names:
  • Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Eradication of H. pylori infection after treatment [4 weeks after end of treatment]

      Negative stool antigen test for H.pylori

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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. -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Helwan University Cairo Egypt 11795

    Sponsors and Collaborators

    • Helwan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Hany Shehata, Principle Investigator, Helwan University
    ClinicalTrials.gov Identifier:
    NCT06050824
    Other Study ID Numbers:
    • ENDM0003
    First Posted:
    Sep 22, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Metronidazole
    Clarithromycin
    Pantoprazole

    Study Results

    No Results Posted as of Sep 26, 2023