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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014