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Completed

NCT Number: NCT01735136

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

InSan Bamboo Salt

Dietary Supplement

InSan Bamboo Salt (10g/day)

Placebo

Dietary Supplement

Placebo (10g/day)

Primary outcomes

  1. Changes in 14C-UBT(Urea breath test)

    Time frame: 4 weeks

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

Secondary outcomes

  1. Changes in subjects' symptoms

    Time frame: 4 weeks

    subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
Aug 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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