None listed
Conditions
Interventions
Dietary Supplement : • Main ingredient name: Gold kiwi lactobacillus fermentation (Kiwibiotics®)
• Properties and Formulations: A light yellowish brown liquid with a unique flavor and no odor, cloth
Sponsors
Semyung University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 19 to 70 2) Subjects who have at least one of the symptoms of dyspepsia* classified as Rome IV and do not require prompt medication (when symptoms start 6 months prior to visit 1 and have symptoms for the past 3 months) * Indigestion symptoms classified as Rome IV - Bothersome postprandial fullness after a meal - Bothersome early satiation - unpleasant epigastric pain - unpleasant epigastric burning 3) Among the eight major symptoms of NDI-K (abdominal pain, epigastric discomfort, epigastric bitterness, early fullness, postprandial satiety, epigastric compression, epigastric bloating, and nausea), at least two of them have moderate (3 points) or higher symptoms and a total score of 6 or higher 4) Subjects who agreed to participate in this study and voluntarily signed a written consent form
Exclusion criteria
Exclusion criteria: 1) History of peptic ulcer and reflux esophagitis within 6 months of visit 1. Subjects with a history of gastrointestinal surgery (excluding appendectomy and hemorrhoids) and subjects with a history of gastrointestinal malignancies 2) H2 receptor blockers, anticholinergics (muscarin receptor antagonists), gastrin receptor antagonists, prostagladin preparations, proton pump inhibitors, gastric mucosa protectors, other drugs for gastritis treatment, and subjects who took gastric health functional foods within 2 weeks of visit 1 3) Subjects who must continue to take drugs that can cause gastritis, such as adrenocortical hormone drugs, nonsteroidal anti-inflammatory drugs, and aspirin during the trial period 4) Subjects with severe cerebrovascular disease (cerebrovascular infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within 6 months of visit 1 (However, subjects who have a history of cerebrovascular disease or heart disease but are clinically stable may participate in the trial at the discretion of the researcher.) 5) In the drinking habits questionnaire, subjects with an average alcohol consumption habits of 210 g/week for men and 140 g/week for women or more per week in the past 1 month 6) Uncontrolled diabetics with fasting blood glucose greater than 180 mg/dL 7) Patients with uncontrolled hypertension (based on blood pressure of 160/100 mmHg or higher and measurement after 10 minutes of rest in subjects) 8) Subjects whose creatine is more than twice the normal upper limit of the testing institution based on visit 1 9) Subjects whose AST (GOT) or ALT (GPT) is at least three times the normal upper limit of the testing agency as of Visit 1 10) Subjects who have not passed three months after participating in human application or clinical trials 11) Subjects who are pregnant, breastfeeding, or who are planning to become pregnant during the human application test period 12) Subjects who have allergic reactions to food for human application testing 13) Subjects deemed unsuitable by the researcher due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in score of gastrointestinal symptom rating scale (GSRS) epigastric symptoms at 8 weeks compared to base;Changes in the Korean version of Nephrotic Indigestion Index (NDI-K) score at 8 weeks compared to the base | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in scores for gastrointestinal symptom rating scale (GSRS) epigastric symptoms at 2 and 4 weeks compared to base;Changes in the Korean version of Nephrotic Indigestion Index (NDI-K) score at 2 weeks and 4 weeks compared to the base;Changes in scores by sub-topic symptoms (reflux, abdominal pain, indigestion) and sub-topic symptoms of the upper abdomen at 2, 4, and 8 weeks points compared to the base;Changes in functional indigestion-related quality of life (FD-QoL) scale scores at 2, 4, and 8 weeks compared to base;Changes in TNF-a, IL-6 at 8 weeks compared to base | — |
Countries
Korea, Republic of
Contacts
Public ContactSeonMi Shin
Semyung University
Outcome results
None listed