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CompletedNCT06050824Updated Sep 26, 2023

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

A Phase 4 interventional study of Comparing Load and Concomitant therapy in H. Pylori Infection, sponsored by Helwan University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Helwan University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jul 2022, registered Sep 2023).
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study 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

Read the 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.

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.

02

Conditions studied

  • H. Pylori Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 200 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Helwan University is the lead sponsor of 69 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients who presented with epigastric pain and dyspeptic symptoms

Exclusion criteria

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. -
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    concomitant

    Clarithro -pantoprazole- Metronidazole - Amoxicyllin

    Drug: Comparing Load and Concomitant therapy

  • Active comparator
    LOAD

    Levofloxacin -omeprazole- nitazoxanide- Doxycycline

    Drug: Comparing Load and Concomitant therapy

Interventions

  • DrugComparing Load and Concomitant therapy

    Levofloxacin - Omeprazole - nitazoxanide - doxycycline

    Also known as: Clarithromycin - pantoprazole - Metronidazole - Amoxycyllin

06

What researchers measure

Primary outcomes

  1. Eradication of H. pylori infection after treatment

    Negative stool antigen test for H.pylori

    Time frame: 4 weeks after end of treatment

07

Study locations

1 site
  • Faculty of Medicine, Helwan University
    Cairo, 11795, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06050824
Lead sponsor
Helwan University
Responsible party
Hala Hany Shehata (Principle Investigator, Helwan University) — Principal investigator
First posted
Sep 22, 2023
Start date
Jul 21, 2022
Primary completion
Jul 19, 2023
Completion
Jul 19, 2023
Last update
Sep 26, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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