Anti-H. Pylori Effect of Deep See Water

NCT01933659 | Completed Phase 3

• 1 other identifier: 201304065RIND
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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. 1.to evaluate the anti-bacterial effects of ingesting DSW in patients with H. pylori infection;
2. 2.to evaluate the patient adherence and adverse effects of ingesting DSW.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; deep see water

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• to compare the adverse effects and patient adherence of DSW and non-DSW drinking water as anti-H. pylori regimen

  6 months

Study Arms (2)

group A: DSW group

EXPERIMENTAL

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

Drug: DSW

group B: non-DSW group

PLACEBO COMPARATOR

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

Interventions

DSW DRUG

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

group A: DSW group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Study Officials

• Jyh-Chin Yang, M.D.Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

TW (1)