Helicobacter Pylori InfectionPhase 3NCT01933659
Anti-H. Pylori Effect of Deep See Water
A Phase 3 study testing DSW in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and minerals and is obtained from the water flows 200 meters under the surface of the sea. The inhibition of H. pylori growth by DSW has been demonstrated in vitro study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- DSW
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Feb 2014
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars who are aged greater than 20 years and are willing to received anti-H. pylori treatment.
Who cannot join
- pregnant or nursing woman
- serious concomitant illness and malignant tumor of any kind
- serious bleeding from gastrointestinal tract
- previous gastric surgery
- receiving bismuth salts, Proton pump inhibitors, or antibiotics in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection
Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and minerals and is obtained from the water flows 200 meters under the surface of the sea. The inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to now, there is few randomized control study to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection.
The aims of this study are:
- to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection;
- to evaluate the patient adherence and adverse effects of ingesting DSW.
Read the detailed description
Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars will be recruited. Before treatment, H. pylori infection status will be examined by endoscopy with biopsy or 13C-urea breath test (13C-UBT). All patients will receive 13C-UBT before treatment, at the end of 2 week's treatment and 4 weeks after termination of treatment. A computed generated random numbers sequence will be blocked (2:1; block sizes of six) into two groups, say A and B.
group A - ingesting DSW 200 cc four times a day (one hour before meal and bed time); group B - ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
To keep the study in double-blind model, the picture of package for DSW and non-DSW drinking water will be the same.
Prokinetics (metoclopramide 5 mg/tab 1 tid) and antacid (strocain tablet (oxethazaine 5 mg and polymigel 244 mg/tab) 1 tid) will be permitted for relieving the dyspeptic symptoms.
All patients will be asked to complete a questionnaire and to record symptoms and water/drug consumption daily during the treatment period. Post-treatment, the patients will be seen at the Outpatients Clinic to investigate patient adherence and adverse of treatment.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- DSW
- Keywords
- Helicobacter pylori, deep see water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSWDrug
ingesting DSW 200 cc four times a day (one hour before meal and bed time)
| Study group | Role | What they receive |
|---|---|---|
| group A: DSW group | Experimental | ingesting DSW 200 cc four times a day (one hour before meal and bed time); Receives: Drug: DSW |
| group B: non-DSW group | Placebo comparator | ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time). |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Measured: 6 months
Secondary outcomes (1)
to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen
The safety and patient adherence will be evaluated by the number of participant with adverse events and by counting unused medication after the treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyh-Chin Yang, M.D.Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933659
- Sponsor's protocol ID
- 201304065RIND
- Status last verified
- May 2014
- First submitted
- 28 Aug 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection
- ClinicalTrials.gov ID
- NCT01933659
- Acronym / sponsor ID
- 201304065RIND
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, deep see water
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 2 Sep 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.
Deep sea water (DSW) is characterized by high purity, low temperature, high nutrients and minerals and is obtained from the water flows 200 meters under the surface of the sea. The inhibition of H. pylori growth by DSW has been demonstrated in vitro study. However, up to now, there is few randomized control study to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection.
The aims of this study are:
- to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection;
- to evaluate the patient adherence and adverse effects of ingesting DSW.
Detailed description
Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars will be recruited. Before treatment, H. pylori infection status will be examined by endoscopy with biopsy or 13C-urea breath test (13C-UBT). All patients will receive 13C-UBT before treatment, at the end of 2 week's treatment and 4 weeks after termination of treatment. A computed generated random numbers sequence will be blocked (2:1; block sizes of six) into two groups, say A and B.
group A - ingesting DSW 200 cc four times a day (one hour before meal and bed time); group B - ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
To keep the study in double-blind model, the picture of package for DSW and non-DSW drinking water will be the same.
Prokinetics (metoclopramide 5 mg/tab 1 tid) and antacid (strocain tablet (oxethazaine 5 mg and polymigel 244 mg/tab) 1 tid) will be permitted for relieving the dyspeptic symptoms.
All patients will be asked to complete a questionnaire and to record symptoms and water/drug consumption daily during the treatment period. Post-treatment, the patients will be seen at the Outpatients Clinic to investigate patient adherence and adverse of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: DSW group | Experimental | Drug: DSWingesting DSW 200 cc four times a day (one hour before meal and bed time); |
| group B: non-DSW group | Placebo comparator | –ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having H. pylori-positive chronic gastritis with/without small erosions or peptic ulcer scars who are aged greater than 20 years and are willing to received anti-H. pylori treatment.
Key exclusion criteria (5 listed)
- pregnant or nursing woman
- serious concomitant illness and malignant tumor of any kind
- serious bleeding from gastrointestinal tract
- previous gastric surgery
- receiving bismuth salts, Proton pump inhibitors, or antibiotics in the previous month.
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 |
|---|---|---|
| DSWingesting DSW 200 cc four times a day (one hour before meal and bed time) | Drug | group A: DSW group |
Primary outcome
to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen
Time frame: 6 months
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
1 secondary outcome
to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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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.
Jyh-Chin Yang, M.D.Ph.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DSW in people with Helicobacter Pylori Infection, run by National Taiwan University 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 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: finished, as of the sponsor's last update on 14 May 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen (time frame: 6 months). 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 May 2014.