Increase the Eradication Rate of Helicobacter PyloriPhase 1NCT01045408
The Effect of Berry Extract on Helicobacter Pylori Eradication
A Phase 1 study testing Berry extract in people with Increase the Eradication Rate of Helicobacter Pylori, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Increase the Eradication Rate of Helicobacter Pylori
- What is being tested?
- Berry extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Jun 2010
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18
Who cannot join
- Pregnancy or breastfeeding
- Use of antibiotics 2 weeks prior to inclusion
- Previous eradication treatment
Trial locations and contacts
1 site in 1 country.
Chian-Sem Chua, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Chian-Sem Chua, MD
About this study
Official title: The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication
Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries.
Read the detailed description
One-week of triple therapy composed of a proton pump inhibitor plus two antibiotics is currently regarded as the gold standard for HP eradication. However, the eradication rate continues to be disappointing. Poor patient compliance and bacterial resistance are the main factors contributing to treatment failure. Therefore, it is urgently necessary to develop a non-antibiotic alternative therapy to increase the eradication rates of Helicobacter pylori. Some literatures reported that cranberry may inhibit Helicobacter pylori adhesion to the human gastric mucus and may reduce Helicobacter pylori infection in adults. The aims of his experiment were to explore the impact of berry extract on triple therapy for Helicobacter pylori eradication.
- Being tested
- Berry extract
- Keywords
- Helicobacter pylori, Berry extract, Triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry extractDietary supplement
Berry extract for weeks
| Study group | Role | What they receive |
|---|---|---|
| Berry | Placebo comparator | Not described Receives: Dietary Supplement: Berry extract |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Berry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
Measured: 4 weeks after Eradication of Helicobacter pylori
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increase the Eradication Rate of 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Yi Huang, Ph.D, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045408
- Sponsor's protocol ID
- SKH-TMU-98-02
- Status last verified
- Jan 2010
- First submitted
- 29 Dec 2009
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjuvant Effect of Berry Extract on Triple Therapy for Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT01045408
- Acronym / sponsor ID
- SKH-TMU-98-02
- Keywords
- Helicobacter pylori, Berry extract, Triple therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 11 Jan 2010 (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.
Helicobacter pylori (HP) is the major risk factors of gastritis, gastric ulcers, duodenal ulcers, mucosa associated lymphoid tissue lymphoma and gastric cancer. Helicobacter pylori are found in 70-90% of the population in developing countries and in 25-50% of developed countries.
Detailed description
One-week of triple therapy composed of a proton pump inhibitor plus two antibiotics is currently regarded as the gold standard for HP eradication. However, the eradication rate continues to be disappointing. Poor patient compliance and bacterial resistance are the main factors contributing to treatment failure. Therefore, it is urgently necessary to develop a non-antibiotic alternative therapy to increase the eradication rates of Helicobacter pylori. Some literatures reported that cranberry may inhibit Helicobacter pylori adhesion to the human gastric mucus and may reduce Helicobacter pylori infection in adults. The aims of his experiment were to explore the impact of berry extract on triple therapy for Helicobacter pylori eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berry | Placebo comparator | Dietary Supplement: Berry extract |
| Placebo | Placebo comparator | Dietary Supplement: Berry extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding
- Use of antibiotics 2 weeks prior to inclusion
- Previous eradication treatment
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 |
|---|---|---|
| Berry extractBerry extract for weeks | Dietary supplement | Berry, Placebo |
Primary outcome
Eradication rate
Time frame: 4 weeks after Eradication of Helicobacter pylori
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
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.
Chian-Sem Chua, MD contact
Shih-Yi Huang, Ph.D principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Berry extract in people with Increase the Eradication Rate of Helicobacter Pylori, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 3 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 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chian-Sem Chua, MD (886-2-28332211 ext. 2241), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: 4 weeks after Eradication of Helicobacter pylori). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2010.