Anti-H. Pylori Effect of Deep See Water

NCT ID: NCT01933659

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-02-28

Brief 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.

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A: DSW group

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

Group Type: EXPERIMENTAL

DSW

Intervention Type: DRUG

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

group B: non-DSW group

ingesting non-DSW drinking water 200 cc four times a day (one hour before meal and bed time).

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

DSW

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jyh-Chin Yang, M.D.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

201304065RIND

Identifier Type: -

Identifier Source: org_study_id