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

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: InSan Bamboo Salt; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo (10g/day)
Experimental: InSan Bamboo Salt	Dietary supplement: InSan Bamboo Salt; InSan Bamboo Salt (10g/day)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in subjects' symptoms	subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).	4 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2012
• Primary Completion (Actual): July 25, 2013
• Study Completion (Actual): July 25, 2013

Study Registration Dates

• First Submitted: November 23, 2012
• First Submitted That Met QC Criteria: November 23, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections
• Other Study ID Numbers: INSAN-HP-BS