None listed
Conditions
Interventions
Dietary Supplement : • HP7 Low-Dose Group: Orally administered 1 stick pack, once a day (after breakfast) for 8 weeks (2,000 mg/day, 1.5×10^9 CFU/day as L. paracasei HP7)
• HP7 High-Dose Group: Orally
Sponsors
Hy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 to 70 at the time of the screening visit. 2) Individuals who tested positive for Helicobacter pylori infection in the Urea Breath Test (13C-UBT). 3) Individuals who have experienced one or more of the following gastrointestinal discomfort symptoms that started at least 6 months prior to the screening visit and persisted for at least the past 3 months: unpleasant postprandial fullness, unpleasant early satiety, unpleasant epigastric pain, or unpleasant epigastric burning/heartburn. 4) Individuals who have been fully informed of and understand the details of this human application trial, voluntarily decide to participate, and provide written consent to comply with the precautions.
Exclusion criteria
Exclusion criteria: 1) Individuals who are unable to undergo upper gastrointestinal endoscopy. 2) Individuals with ulcers, cancer, hemorrhagic gastritis, or other conditions requiring treatment found during the upper gastrointestinal endoscopy, or those judged to have a tendency for gastrointestinal bleeding. 3) Individuals whose upper gastrointestinal endoscopy results necessitate immediate eradication therapy. 4) Individuals with diseases that could be an organic cause of gastrointestinal discomfort within 3 months prior to the screening visit. 5) Individuals who have taken drugs that could interfere with the study within 2 weeks prior to the screening visit, such as antibiotics, bowel-regulating agents, bismuth compounds, antacids, H2 receptor antagonists, or proton pump inhibitors. 6) Individuals who have consumed functional foods related to gastric health within 2 weeks prior to the screening visit. 7) Individuals with a BMI less than 18.5 kg/m^2 or greater than 35 kg/m^2 at the time of the screening visit. 8)Individuals who have received antipsychotic medication treatment within 3 months prior to the screening visit. 9) Individuals with a history of significant hypersensitivity reactions or side effects to the components of the investigational product. 10) Individuals who have participated in other human application trials within 3 months prior to the screening visit. 11) Individuals with known or suspected alcoholism or substance abuse. 12) Women who are pregnant or breastfeeding. 13) Women of childbearing potential who do not agree to use appropriate contraceptive methods. 14) Individuals who are judged to be unsuitable for study participation by the Principal Investigator due to other reasons, including results from diagnostic laboratory tests.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Nepean Dyspepsia Index-Korean version, WHO Quality of Life-BREF;Gastrin-17, Pepsinogen ;H. pylori Immunoglobulin;histamin | — |
Primary
| Measure | Time frame |
|---|---|
| KGSRS(Gastrointestinal Symptom Rating Scale for Korean version ) ;13C-Urea breath test | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo Jongcheon
Wonkwang University Oriental Medical Hospital, Jeonju
Outcome results
None listed