Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT01933659
Status:
COMPLETED
Last Update Posted:
2014-05-14
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-H. Pylori Effect of Deep See Water
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Anti-bacterial Effects of Ingesting Deep Sea Water in Subjects With H. Pylori Infection
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: