Helicobacter-associated Gastritis Clinical Trial
Official title:
Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori
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 .
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01888237 -
High Dose PPI Triple Therapy Versus Sequential Therapy for Helicobacter Pylori Eradication
|
Phase 4 | |
| Completed |
NCT01434992 -
Detection of Helicobacter Pylori Infection by High Resolution Endoscopy
|
N/A |