Positivity for Helicobacter PyloriCurHPNCT02018328
The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
A study testing Curcumin in people with Positivity for Helicobacter Pylori, run by Gingold Belfer Rachel at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positivity for Helicobacter Pylori
- What is being tested?
- Curcumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- positivity for Helicobacter pylori by urease test and gastric biopsy
Who cannot join
- prior treatment for H. pylori
- allergy to penicillin
- gastric outlet obstruction
- pregnancy or breast feeding
- inability to understand the informed consent
Trial locations and contacts
2 sites in 1 country.
Rachel Gingold belfer, MD contact
Israel2 sites
Rabin Medical Center
Petah Tikva, 49100
Rachel Gingold Belfer, MD, 974-54-2405895, RahelGB@clalit.org.il
Rachel Gingold Belfer, MD
Rabin Medical Center
Petah Tikva
Rachel Gingold Belfer, MD, 974-54-2405895, RahelGB@clalit.org.il
Rachel Ginold Belfer, MD
About this study
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.
Read more
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
- Being tested
- Curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy, helicobacter pylori | No intervention | Not described |
| triple therapy+curcumin helicobacter pylori | Experimental | Curcumin will be added to the regular triple therapy Receives: Dietary Supplement: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urea breath test
Measured: 6 weeks after the completion of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Positivity for Helicobacter PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gingold Belfer Rachel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gingold Belfer Rachel, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018328
- Sponsor's protocol ID
- rmc137511
- Acronym
- CurHP
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2013
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15044093
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Addition of Curcumin for 10 Days Triple Therapy, on the Eradication Rate of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02018328
- Acronym / sponsor ID
- CurHP / rmc137511
- Conditions
- Positivity for Helicobacter Pylori
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gingold Belfer RachelUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple therapy, helicobacter pylori | No intervention | – |
| triple therapy+curcumin helicobacter pylori | Experimental | Dietary Supplement: CurcuminCurcumin will be added to the regular triple therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- positivity for Helicobacter pylori by urease test and gastric biopsy
Key exclusion criteria (5 listed)
- prior treatment for H. pylori
- allergy to penicillin
- gastric outlet obstruction
- pregnancy or breast feeding
- inability to understand the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin | Dietary supplement | triple therapy+curcumin helicobacter pylori |
Primary outcome
Urea breath test
Time frame: 6 weeks after the completion of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Background: PubMed 15044093Foryst-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Gingold belfer, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Positivity for Helicobacter Pylori, run by Gingold Belfer Rachel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Gingold belfer, MD (RahelGB@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urea breath test (time frame: 6 weeks after the completion of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2014.