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

NCT01735136 | Completed DMC

• 1 other identifier: INSAN-HP-BS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in subjects' symptoms

  4 weeks

Study Arms (2)

InSan Bamboo Salt

EXPERIMENTAL

Dietary Supplement: InSan Bamboo Salt

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

InSan Bamboo Salt DIETARY_SUPPLEMENT

InSan Bamboo Salt (10g/day)

InSan Bamboo Salt

Placebo DIETARY_SUPPLEMENT

Placebo (10g/day)

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 19-65 years old
• C-UBT test ≥ 100 cpm
• Endoscopy results showing gastritis
• Able to give informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: November 23, 2012
• First Posted: November 28, 2012
• Study Start: November 21, 2012
• Primary Completion: July 25, 2013
• Study Completion: July 25, 2013
• Last Updated: August 26, 2019

Record last verified: 2019-08

Locations

KR (1)