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Anti-H. Pylori Effect of Deep See Water

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01933659
First Posted: September 2, 2013
Last Update Posted: May 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose

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:

  1. to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection;
  2. to evaluate the patient adherence and adverse effects of ingesting DSW.

Condition Intervention Phase
Helicobacter Pylori Infection Drug: DSW Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen [ Time Frame: 6 months ]
    The safety and patient adherence will be evaluated by the number of participant with adverse events and by counting unused medication after the treatment.


Enrollment: 54
Study Start Date: September 2013
Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group A: DSW group
ingesting DSW 200 cc four times a day (one hour before meal and bed time);
Drug: DSW
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).

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933659


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jyh-Chin Yang, M.D.Ph.D. National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01933659     History of Changes
Other Study ID Numbers: 201304065RIND
First Submitted: August 28, 2013
First Posted: September 2, 2013
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by National Taiwan University Hospital:
Helicobacter pylori
deep see water

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections