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

This study is currently recruiting participants.
Verified November 2012 by Chonbuk National University Hospital
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01735136
First received: November 23, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Helicobacter Pylori Infection
Dietary Supplement: InSan Bamboo Salt
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in 14C-UBT(Urea breath test) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: InSan Bamboo Salt Dietary Supplement: InSan Bamboo Salt
InSan Bamboo Salt (10g/day)
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (10g/day)

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 23, 2012
Last Updated: November 27, 2012
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014