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

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ClinicalTrials.gov Identifier: NCT01735136
Recruitment Status : Unknown
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2012
Last Update Posted : November 29, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Dietary Supplement: InSan Bamboo Salt Dietary Supplement: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : November 2012
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: InSan Bamboo Salt Dietary Supplement: InSan Bamboo Salt
InSan Bamboo Salt (10g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (10g/day)


Outcome Measures
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Primary Outcome Measures :
  1. Changes in 14C-UBT(Urea breath test) [ Time Frame: 4 weeks ]
    14C-UBT(Urea breath test) was measured in study visit 1(0 week) and visit 3(4 week).


Secondary Outcome Measures :
  1. Changes in subjects' symptoms [ Time Frame: 4 weeks ]
    subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735136


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital Recruiting
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Contact: Seung-Ok Lee, MD., PhD    82-63-250-1289    hyangim100@gmail.com   
Sponsors and Collaborators
Chonbuk National University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01735136     History of Changes
Other Study ID Numbers: INSAN-HP-BS
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections