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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2012 by Chonbuk National University Hospital.
Recruitment status was Recruiting

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

History of Changes

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:

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Sodium chloride

U.S. FDA Resources

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 Infection Bacterial Infections Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on February 27, 2015

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