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

This study is not yet open for participant recruitment.
Verified December 2013 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Gingold Belfer Rachel, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT02018328
First received: December 17, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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

Condition Intervention
Positivity for Helicobacter Pylori
Dietary Supplement: Curcumin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Urea breath test [ Time Frame: 6 weeks after the completion of the treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Triple therapy, helicobacter pylori
Experimental: triple therapy+curcumin helicobacter pylori
Curcumin will be added to the regular triple therapy
Dietary Supplement: Curcumin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02018328

Contacts
Contact: Rachel Gingold belfer, MD RahelGB@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah tikva, Israel
Contact: Rachel Gingold Belfer, MD    974-54-2405895    RahelGB@clalit.org.il   
Principal Investigator: Rachel Ginold Belfer, MD         
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Rachel Gingold Belfer, MD    974-54-2405895    RahelGB@clalit.org.il   
Principal Investigator: Rachel Gingold Belfer, MD         
Sponsors and Collaborators
Gingold Belfer Rachel
  More Information

Publications:
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

Responsible Party: Gingold Belfer Rachel, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02018328     History of Changes
Other Study ID Numbers: rmc137511
Study First Received: December 17, 2013
Last Updated: December 20, 2013
Health Authority: Israel: Clalit Health Services

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014