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

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Dietary Supplement: InSan Bamboo Salt; Dietary Supplement: Placebo

• Registration Number: NCT01735136
• Lead Sponsor: Chonbuk National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-21
• Study First Submitted: 2012-11-23
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-28
• Primary Completion: 2013-07-25
• Study Completion: 2013-07-25
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
InSan Bamboo Salt	InSan Bamboo Salt	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of