None listed
Conditions
Interventions
Dietary Supplement : 1. Placebo group
- Placebol 4g, 3 PO/day administration, 28 days
2. Test group
- SL-10 4g, 3 PO/day administration, 28 days
Sponsors
GeneChem
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged 19 to 70 years with Helicobacter pylori positive (= 2.6 permil in 13C-urea breath test at screening) 2. Subject who voluntarily agreed to participation in this study and signed informed consent prior to performing any of the screening procedures 3. Subjects who are willing and able to comply with scheduled visits (it was judged by investigator)
Exclusion criteria
Exclusion criteria: 1. A Subject with evidence or history of ulcer or cancer within 1 month prior to screening test 2. A subject with history of allergies including drug allergies or history of clinically significant allergies 3. A subject with history of gastrointestinal disease (e.g. Crohn’s disease) or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug 4. Use of drugs affecting Helicobacter pylori infection such as steroids, bismuth compounds, proton pump inhibitors, antibiotics, etc. within 1 month prior to screening test (However, investigators can judge the subject, who has taken the medications during those periods above, eligible for the trial if all other conditions are satisfied.) 5. A Subjects with history of pyloric diseases including obstruction within 1 year prior to screening test 6. A subject who abuse drug or alcohol 7. A Subject with history of stomach or duodenum surgery or has any scheduled surgical interventions on stomach or duodenum during the study period 8. A Subject with current gastrointestinal bleeding 9. The investigator judges the subject not eligible for the study after reviewing clinical laboratory results or other reasons 10. Lactating or pregnant woman 11. Woman with child bearing potential who do not agree to use reliable contraception during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| delta 13C-ureabreathtest(UBTvalues) at Week 4 compared with baseline;Safety evaluation: Adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign, Physical exam, 12-lead ECG, Laboratory test(CBC, Chemistry, Urine) | — |
Countries
Korea, Republic of
Contacts
Public ContactHee Moon
Chungnam National University Hospital
Outcome results
None listed