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Completed

NCT Number: NCT01933659

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:

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSW

Drug

ingesting DSW 200 cc four times a day (one hour before meal and bed time)

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Sep 2, 2013
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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