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Helicobacter-associated GastritisPhase 3NCT02422706

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

A Phase 3 study testing Nitazoxanide, Metronidazole(MTZ) and Omeprazole in people with Helicobacter-associated Gastritis, run by Sherief Abd-Elsalam at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one of a global standard care for confirmed H.pylori infection . Read more about this study

Who is it for?
Any age
Conditions the study is for
Helicobacter-associated Gastritis
What is being tested?
Nitazoxanide, Metronidazole(MTZ) and Omeprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteEgypt
Study dates
Jan 2015to Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Consecutive patients with dyspeptic symptoms undergoing upper Gasto-intestinal tract (GIT) endoscopy selecting HP infected patients to be recruited for the study.
  • Patients must have had Helicobacter Pylori - induced disease confirmed by endoscopy and HP monoclonal stool antigen.

Who cannot join

  • Previous gastric or duedenal operations or malignancy.
  • Active GIT bleeding.
  • Pregnancy.
  • Previous treatment for HP.
  • Current use of Antiacids ( proton pump inhibitor ( PPI ), H2 receptor antagonist) , anticoagulant, or recent use of antibiotics (within 6 weeks).
  • Allergy to any medication included in the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting

  • Tanta university hospital

    Cairo

    Sherief Abd-Elsalam, 00201000040794, Sherif_tropical@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance .

However, a recent study based on the Maastricht III guidelines, indicated that treatment with a PPI-based triple regimen as first-line therapy will fail in ~30% of patients on an intention-to-treat (ITT) basis, and will fail in ~ 50 % of patients who treated with PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue warranting the investigation of other agents. 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 .

Read the detailed description

Helicobacter pylori (H.pylori) is a small, Gram-negative spirochete inhabiting the mucous layer overlying the gastric epithelial cells in humans. It is the most common prevalent chronic human bacterial infection and the most common cause of gastritis worldwide;. Furthermore, according to the World Health Organization, HP is classified as a type 1 carcinogen and is the primary cause of peptic ulcer disease, gastric carcinoma, and mucosa-associated lymphoid tissue lymphomas .

Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens.Omeprazole,Amoxicillin \&Clarithromycin is one of a global standard care for confirmed H.pylori infection .Metronidazole (MTZ) is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance .

However, a study by Rokkas , et al., 2008 based on the Maastricht III guidelines, indicated that treatment with a PPI-based triple regimen as first-line therapy will fail in ~30% of patients on an intention-to-treat (ITT) basis,and will fail in ~ 50 % of patients who treated with PPI-based triple regimen with Metronidazole.This treatment resistance is also an issue warranting the investigation of other agents . 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.

Nitazoxanide (NTZ) is an antibiotic with microbiological characteristics similar to those of Metronidazole which was sittled as a therapy for intestinal protozoa and helminthic infection,and was studied as an additional therapy with Peg Interferon and Ribavirin for chronic hepatitis C virus (HCV) .

In the last few years Nitazoxanide was evaluated as a single agent therapy for H. Pylori infection showing controversed results.. However (NTZ) based regimens were recently studied showing interesting results without the apparent problem of resistance as Metronidazole with nearby cost.Moreover ;Levofloxacin,PPI,NTZ\&Doxycycline (LOAD) regimen with very good results in H.pylori infection ~90% cure rate..But uptil now there are no actual similar reported trials in Egypt.

Being tested
Nitazoxanide, Metronidazole(MTZ), Omeprazole, Clarithromycin, Levofloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitazoxanideDrug

    Also called Alenia,parazoxanide,Nitclean

    Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection

  • Metronidazole(MTZ)Drug

    Also called Flagyl

    Metronidazole 500 mg twice daily

  • OmeprazoleDrug

    Also called Omepak. Napizole

    Omeprazole 20 twice daily

  • ClarithromycinDrug

    Also called KLacid

    KLacid twice daily

  • LevofloxacinDrug

    Also called Levofloxacin once daily

    Tavanic. Tavacin

  • DoxicyclineDrug

    Also called vibramycin. Doxymycin

    Vibramycin 100 mg twice daily

Study groups in NCT02422706
Study groupRoleWhat they receive
group IActive comparatorMetronidazole(MTZ) 500mg twice daily ,Omeprazole 20 mg twice daily as (Proton Pump Inhibitor (PPI)\& Clarithromycin 500 mg twice daily .for 14 days . 40 patients
Receives: Drug: Metronidazole(MTZ); Drug: Omeprazole; Drug: Clarithromycin
Group IIExperimentalNitazoxanide(NTZ)500 mg twice daily ,PPI 20 mg twice daily \& Clarithromycin 500 mg twice daily for 14 days. 40 patients.
Receives: Drug: Nitazoxanide; Drug: Clarithromycin
Group IIIExperimentalLevofloxacin 250 mg once daily,Omeprazole 40mg once daily(PPI),Nitazoxanide (NTZ) 500mg twice daily \& Doxicycline 100 mg once daily (LOND). 40 patients
Receives: Drug: Nitazoxanide; Drug: Omeprazole; Drug: Levofloxacin; Drug: Doxicycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with proven eradication of helicobacter

    Number of patients with proven eradication of helicobacter after 6 weeks

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02422706
Sponsor's protocol ID
HELICOBACTER NEW TREATMENT
Status last verified
Apr 2017
First submitted
13 Apr 2015
Last updated
25 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Shehata MA, Talaat R, Soliman S, Elmesseri H, Soliman S, Abd-Elsalam S. Randomized controlled study of a novel triple nitazoxanide (NTZ)-containing therapeutic regimen versus the traditional regimen for eradication of Helicobacter pylori infection. Helicobacter. 2017 Oct;22(5). doi: 10.1111/hel.12395. Epub 2017 May 19.

    PubMed 28524341

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nitazoxanide, Metronidazole(MTZ) and Omeprazole in people with Helicobacter-associated Gastritis, run by Sherief Abd-Elsalam at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with proven eradication of helicobacter (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02422706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.

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