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Status unknownNCT03491995Updated Apr 10, 2018

A Unique Regimen for Treatment of Helicobacter Pylori Infection

A Phase 3 interventional study of Quadruple therapy and Classic treatment in Helicobacter Infections, sponsored by Sherief Abd-Elsalam. Status unknown at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.

However, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective

Read the detailed description

Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .

02

Conditions studied

  • Helicobacter Infections
03

In context

Helicobacter Infections

53 studies on the registry are indexed under Helicobacter Infections; 9 are open to participants now.

This study's planned enrollment of 600 is above the median of 216 across 34 interventional studies indexed under Helicobacter Infections.

Browse Helicobacter Infections studies →

Lead sponsor

Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent

Exclusion criteria

Exclusion Criteria:

  • Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Quadruple therapy

    Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin

    Drug: Quadruple therapy

  • Active comparator
    Classic treatment

    Omeprazole, clarithromycin, amoxicillin

    Drug: Classic treatment

Interventions

  • DrugQuadruple therapy

    Drug pages: Esomeprazole · Metronidazole · Bismuth tripotassium dicitrate · Tetracycline

    Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin

    Also known as: Moxiflox, Downoprazol, Nanazoxid, Doxymycin

  • DrugClassic treatment

    Omeprazole, amoxycillin, clarithromycin

    Also known as: Downoprazol, Emox, Klacid

06

What researchers measure

Primary outcomes

  1. Number of patients with eradicated Helicobacter infection

    Number of patients with eradicated infection

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Sherief Abd-Elsalam
    Tanta, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2018 (actual). Primary completion is estimated for Apr 2023, 60 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 9, 2018
StartActual
Apr 1, 2018
Primary completionEst.
Apr 1, 2023
CompletionEst.
Apr 1, 2023
Last update
Apr 10, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03491995
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Investigator, Tanta University) — Sponsor-investigator
First posted
Apr 9, 2018
Start date
Apr 1, 2018
Primary completion
Apr 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Apr 10, 2018

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Ayman Yousry, Prof
principal investigator · Head of Hepatology and infectious diseases dept.-Cairo University
Walied El-Hossary, MD
study director · Hepatology and infectious diseases dept.-Cairo University
Mohamed Alboraie, MD
study chair · Internal Medicine dept.-Alazhar University
Sherief Abd-Elsalam, MD
study chair · Hepatology and Infectious diseases- Tanta University
Asem Elfert, Prof
study chair · Hepatology and Infectious diseases- Tanta University
Hussein A Elamin, Prof
study chair · Internal Medicine-Assuit University
Mohamed Adel Elbasiony, MD
study chair · Internal Medicine- Mansoura University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Esomeprazole · Metronidazole · Bismuth tripotassium dicitrate · Tetracycline

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Sherief Abd-Elsalam

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