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

Gingold Belfer Rachel

Status: Unknown

Conditions: Positivity for Helicobacter Pylori

Treatments: Dietary Supplement: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02018328

rmc137511

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Triple therapy, helicobacter pylori

No Intervention group

triple therapy+curcumin helicobacter pylori

Experimental group

Description:

Curcumin will be added to the regular triple therapy

Treatment:

Dietary Supplement: Curcumin