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Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
InSan Bamboo Salt
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Helicobacter Pylori Infection

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Males and females 19-65 years old
  • 14C-UBT test ≥ 100 cpm
  • Endoscopy results showing gastritis
  • Able to give informed consent

Exclusion Criteria:

  • Diagnosed of gastrointestinal disease such as ulcer, cancer, more than 10 erosions
  • Taken antibiotics and stomach medicines such as steroid, bismuth compound, H2-receptor antagonist and proton pump inhibitor within 2 weeks
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months
  • Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
  • Pregnant or lactating women etc.

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

InSan Bamboo Salt

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Changes in 14C-UBT(Urea breath test)
14C-UBT(Urea breath test) was measured in study visit 1(0 week) and visit 3(4 week).

Secondary Outcome Measures

Changes in subjects' symptoms
subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).

Full Information

First Posted
November 23, 2012
Last Updated
August 21, 2019
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01735136
Brief Title
Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 21, 2012 (Actual)
Primary Completion Date
July 25, 2013 (Actual)
Study Completion Date
July 25, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators performed a 4-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of InSan Bamboo Salt on improvement of Helicobacter pylori infection. The investigators measured improvement of Helicobacter pylori infection parameters , including 14C-UBT(Urea breath test), and subjects' symptoms, and monitored their blood pressure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
InSan Bamboo Salt
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
InSan Bamboo Salt
Intervention Description
InSan Bamboo Salt (10g/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo (10g/day)
Primary Outcome Measure Information:
Title
Changes in 14C-UBT(Urea breath test)
Description
14C-UBT(Urea breath test) was measured in study visit 1(0 week) and visit 3(4 week).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in subjects' symptoms
Description
subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females 19-65 years old 14C-UBT test ≥ 100 cpm Endoscopy results showing gastritis Able to give informed consent Exclusion Criteria: Diagnosed of gastrointestinal disease such as ulcer, cancer, more than 10 erosions Taken antibiotics and stomach medicines such as steroid, bismuth compound, H2-receptor antagonist and proton pump inhibitor within 2 weeks Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection

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