The Impact of Addition of Curcumin for 10 Days Triple The... | NCT02018328

Studies
The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection

NCT02018328

Sponsor

Gingold Belfer Rachel

Status

Unknown status

Last Update Posted

Dec 16, 2014Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Positivity for Helicobacter Pylori

Interventions

Curcumin

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 17, 2013

First Submission Date that Met QC Criteria

Dec 20, 2013

First Posted Date

Dec 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Triple therapy, helicobacter pylori	No Intervention
triple therapy+curcumin helicobacter pylori	Experimental	Curcumin will be added to the regular triple therapy	Dietary Supplement: Curcumin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Curcumin	Dietary Supplement		triple therapy+curcumin helicobacter pylori

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urea breath test		6 weeks after the completion of the treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rachel Gingold belfer, MD	Contact			RahelGB@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center		Petah Tikva		49100	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15044093	Background	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.

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic