Anti-H. Pylori Effect of Deep See Water
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection|
- to compare the efficacy of DSW and non-DSW drinking water as anti-H. pylori regimen [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
- to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The safety and patient adherence will be evaluated by the number of participant with adverse events and by counting unused medication after the treatment.
|Study Start Date:||September 2013|
|Study Completion Date:||February 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: group A: DSW group
ingesting DSW 200 cc four times a day (one hour before meal and bed time);
ingesting DSW 200 cc four times a day (one hour before meal and bed time)
Placebo Comparator: group B: non-DSW group
ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01933659
|National Taiwan University Hospital|
|Taipei, Taiwan, 10002|
|Principal Investigator:||Jyh-Chin Yang, M.D.Ph.D.||National Taiwan University Hospital|