None listed
Conditions
Interventions
Dietary Supplement : After voluntarily signing the informed consent form, participants are screened and enrolled in the study if they meet the eligibility criteria. Participants are randomly assigned
Sponsors
Ildong Bioscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects exhibiting at least one symptom associated with functional gastrointestinal disorders Male and female subjects aged between 19 and 70 years Subjects who fully understand the purpose of the study and voluntarily provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects with acute gastrointestinal infections or peptic ulcers 2) Subjects with diseases causing severe immunosuppression 3) Subjects currently undergoing treatment for cardiovascular, immune, respiratory, hepatobiliary, renal/urinary, neurological, musculoskeletal, psychiatric, infectious diseases, or malignancies, and whose conditions are not adequately controlled by medication and require active therapeutic intervention 4) Subjects with a history of gastrointestinal surgery (except for appendectomy and cesarean section) 5) Subjects who have taken medications that may affect gastrointestinal assessments within the past 2 weeks, including: i. Probiotics, prebiotics, synbiotics, or postbiotics ii. Antibiotics iii. Corticosteroids (high-dose, e.g., prednisolone > 20 mg) iv. Antidepressants v. Antihistamines vi. Non-steroidal anti-inflammatory drugs (NSAIDs) vii. Other medications affecting gastrointestinal motility (e.g., laxatives, antidiarrheals, prokinetics, antispasmodics) 6) Subjects with a life expectancy of less than 12 months 7) Subjects who have been diagnosed with gastrointestinal diseases (e.g., ulcerative colitis, Crohn's disease, celiac disease, colorectal cancer) within the past 2 years 8) Subjects with psychiatric disorders such as depression, schizophrenia, alcoholism, or drug addiction 9) Pregnant or lactating women, or women of childbearing potential who plan to become pregnant or breastfeed during the study period 10) Subjects with known hypersensitivity to the investigational product or any of its components, or known allergies to specific ingredients 11) Subjects who have participated in another clinical trial within the past 3 months 12) Subjects who, in the opinion of the investigator, are unable to comply with the study protocol or are otherwise deemed unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data collection and analysis by questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiome analysis;Metabolite analysis;Clinical pathology tests (complete blood count and urinalysis);Assessment of vital signs | — |
Countries
Korea, Republic of
Contacts
Public ContactJongbeom Shin
Inha University Hospital
Outcome results
None listed