Anti-H. Pylori Effect of Deep See Water

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933659
• Other study ID #: 201304065RIND
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2013
• Last updated: May 12, 2014
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes