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

NCT02018328 | Unknown

• 1 other identifier: rmc137511
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Conditions

Positivity for Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• Urea breath test

  6 weeks after the completion of the treatment

Study Arms (2)

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

Curcumin DIETARY_SUPPLEMENT

triple therapy+curcumin helicobacter pylori

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• positivity for Helicobacter pylori by urease test and gastric biopsy

You may not qualify if:

• prior treatment for H. pylori
• allergy to penicillin
• gastric outlet obstruction
• pregnancy or breast feeding
• inability to understand the informed consent

Sponsors & Collaborators

• Gingold Belfer Rachel: lead

Study Sites (2)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

• 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.

  PMID: 15044093 BACKGROUND

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Central Study Contacts

Rachel Gingold belfer, MD

CONTACT

RahelGB@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

IL (2)