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

Chonbuk National University

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Dietary Supplement: InSan Bamboo Salt; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01735136

INSAN-HP-BS

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

InSan Bamboo Salt

Experimental group

Treatment:

Dietary Supplement: InSan Bamboo Salt

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo