Anti-H. Pylori Effect of Deep See Water

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01933659
First received: August 28, 2013
Last updated: May 12, 2014
Last verified: May 2014
  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
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

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 ] [ Designated as safety issue: Yes ]
    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 ] [ 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.


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01933659     History of Changes
Other Study ID Numbers: 201304065RIND
Study First Received: August 28, 2013
Last Updated: May 12, 2014
Health Authority: Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on October 19, 2014