Helicobacter Pylori Infection
Conditions
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.
Interventions
DIETARY_SUPPLEMENTInSan Bamboo Salt
InSan Bamboo Salt (10g/day)
DIETARY_SUPPLEMENTPlacebo
Placebo (10g/day)
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in subjects' symptoms | 4 weeks | subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week). |
Countries
South Korea
Outcome results
None listed