Clinical trial NCT02422706: Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori
Official title: Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Helicobacter-associated Gastritis
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2015-04-21
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 . 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 .

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of patients with proven eradication of helicobacter
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: liver dis dept
name: Mona AH Shehata, Prof
role: STUDY_CHAIR
affiliation: Division of Gastroenterology and Hepatology- Tanta
name: Sherief Abd-Elsalam, Consultant
role: STUDY_DIRECTOR
affiliation: Microbiology
name: Raghda Talaat, Prof
role: STUDY_CHAIR
affiliation: liver diseases dept.-Elmahalla hospital
name: Huda Elmesseri, Specialist
role: STUDY_CHAIR
References:
citation: 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.