Anti-H. Pylori Effect of Deep See Water

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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 28, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Helicobacter pylori; deep see water
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 201304065RIND