The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
NCT ID: NCT02018328
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2014-01-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Triple therapy, helicobacter pylori
No interventions assigned to this group
triple therapy+curcumin helicobacter pylori
Curcumin will be added to the regular triple therapy
Curcumin
Interventions
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Curcumin
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* allergy to penicillin
* gastric outlet obstruction
* pregnancy or breast feeding
* inability to understand the informed consent
18 Years
ALL
Yes
Sponsors
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Gingold Belfer Rachel
OTHER
Responsible Party
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Gingold Belfer Rachel
MD
Locations
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Rabin Medical Center
Petah Tikva, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Rachel Gingold Belfer, MD
Role: primary
Rachel Gingold Belfer, MD
Role: primary
References
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Foryst-Ludwig A, Neumann M, Schneider-Brachert W, Naumann M. Curcumin blocks NF-kappaB and the motogenic response in Helicobacter pylori-infected epithelial cells. Biochem Biophys Res Commun. 2004 Apr 16;316(4):1065-72. doi: 10.1016/j.bbrc.2004.02.158.
Other Identifiers
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rmc137511
Identifier Type: -
Identifier Source: org_study_id