Positivity for Helicobacter Pylori Clinical Trial
— CurHPOfficial title:
The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
Background and Aims
- H.pylori is a common human pathogen by which almost 50% of the world population is
infected. According to the accepted guidelines, once H.pylori infection has been
diagnosed,first line therapy with three drugs should be given. The triple treatment
includes proton-pump-inhibitor-clarithromycin-amoxicillin but its eradication rate is
only 70-80%.
- Curcumin has many beneficial merits and it was also been demonstrated to be efficient
in inhibition of H.pylori infection, in vitro.Therefore we aim to investigate whether
addition of Curcumin to the standard triple therapy will increase the eradication rate
of H.pylori infection.
Methods
- 150 consecutive patients that will undergo esophagogastroscopy in our Gastroenterology
department and will be positive for H.pylori according to urease test and then by
gastric biopsy, will be included. The patients will be randomized to two different
treatments, according to binomial distribution. 75 patients will be treated with the
standard triple therapy for 10 days and the other 75, will be treated for 10 days, with
triple therapy combined with Curcumin that will be given three times a day.
- During the treatment the patients will complete an adverse effect's questionnaires. 6
weeks after the completion of the treatment the patients will undergo urea breath test
to confirm eradication. Patients will be asked to avoid antibiotics, bismuth compounds
or proton-pump-inhibitor until the second urea-breath-test.
- We will compare the eradication rate and the adverse effects between the two groups by
using SPSS
| Status | Not yet recruiting |
| Enrollment | 150 |
| Est. completion date | |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - positivity for Helicobacter pylori by urease test and gastric biopsy Exclusion Criteria: - prior treatment for H. pylori - allergy to penicillin - gastric outlet obstruction - pregnancy or breast feeding - inability to understand the informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center | Petah Tikva | |
| Israel | Rabin Medical Center | Petah tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Gingold Belfer Rachel |
Israel,
Malfertheiner P, Megraud F. Management of helicobacter pylori infection - the Maastricht IV/Florence Consensus Report. Gut.61 (5):646-64.2012 Hatcher H , Planalp R . Curcumin: from ancient medicine to cuurent clinical trials. Cell Mol Life Sci. 65(11):1631-52. 2008. Forty-Ludwig A, Neumann M. Curcumin blocks NF-kappaB and the motogenic response in Helicobacter pylori - infected epithelial cells. Biochem Biophys Res Commun. 316(4): 1065-72. 2004
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Urea breath test | 6 weeks after the completion of the treatment | No |