Anti-H. Pylori Effect of Deep See Water
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
DSW
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, deep see water
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
group A: DSW group
group B: non-DSW group
Arm Description
ingesting DSW 200 cc four times a day (one hour before meal and bed time);
ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01933659
First Posted
August 28, 2013
Last Updated
May 12, 2014
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01933659
Brief Title
Anti-H. Pylori Effect of Deep See Water
Official Title
Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, deep see water
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A: DSW group
Arm Type
Experimental
Arm Description
ingesting DSW 200 cc four times a day (one hour before meal and bed time);
Arm Title
group B: non-DSW group
Arm Type
Placebo Comparator
Arm Description
ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
Intervention Type
Drug
Intervention Name(s)
DSW
Intervention Description
ingesting DSW 200 cc four times a day (one hour before meal and bed time)
Primary Outcome Measure Information:
Title
to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen
Description
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen
Description
The safety and patient adherence will be evaluated by the number of participant with adverse events and by counting unused medication after the treatment.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Chin Yang, M.D.Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
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Anti-H. Pylori Effect of Deep See Water
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