Efficacy and Safety of InSan Bamboo Salt on Improvement of Helicobacter Pylori Infection
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ClinicalTrials.gov Identifier: NCT01735136 |
Recruitment Status
: Unknown
Verified November 2012 by Soo-Wan Chae, Chonbuk National University Hospital.
Recruitment status was: Recruiting
First Posted
: November 28, 2012
Last Update Posted
: November 29, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Helicobacter Pylori Infection | Dietary Supplement: InSan Bamboo Salt Dietary Supplement: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | November 2012 |
Estimated Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: InSan Bamboo Salt |
Dietary Supplement: InSan Bamboo Salt
InSan Bamboo Salt (10g/day)
|
Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Placebo (10g/day)
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- 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).
- Changes in subjects' symptoms [ Time Frame: 4 weeks ]subjects' symptoms was measured in study visit 1(0 week) and visit 3(4 week).

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Ages Eligible for Study: | 19 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735136
Korea, Republic of | |
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Recruiting |
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822 | |
Contact: Seung-Ok Lee, MD., PhD 82-63-250-1289 hyangim100@gmail.com |
Responsible Party: | Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital |
ClinicalTrials.gov Identifier: | NCT01735136 History of Changes |
Other Study ID Numbers: |
INSAN-HP-BS |
First Posted: | November 28, 2012 Key Record Dates |
Last Update Posted: | November 29, 2012 |
Last Verified: | November 2012 |
Additional relevant MeSH terms:
Infection Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections |