None listed
Conditions
Interventions
Dietary Supplement : Among participants who voluntarily provide informed consent to participate in the human clinical trial, eligibility will be determined at the screening visit by assessing whether
Sponsors
Ildong Bioscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 19 to 65 years. Individuals meeting the Rome IV criteria for functional constipation. Individuals who voluntarily agree to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Individuals who meet the criteria for irritable bowel syndrome (IBS). 2) Individuals who have taken, within the past 2 weeks, any medications, herbal medicines, or probiotic preparations that may affect constipation symptoms. 3) Individuals diagnosed with, or currently receiving treatment for, acute or chronic gastrointestinal diseases (e.g., Crohn’s disease, celiac disease, ulcerative colitis, or colorectal malignancy). 4) Individuals with a history of gastrointestinal or liver-related surgery (except appendectomy). 5) Individuals with a history of viral liver disease (hepatitis), malignancy, psychiatric disorders, or autoimmune diseases. 6) Individuals currently following a diet regimen for weight control. 7) Individuals with uncontrolled diabetes despite medication (fasting plasma glucose = 126 mg/dL while taking antidiabetic medication). 8) Individuals with uncontrolled hypertension despite medication (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg while taking antihypertensive medication). 9) Individuals with a history of intestinal disease (e.g., ulcerative colitis, Crohn’s disease, celiac disease, colorectal cancer) within the past 2 years. 10) Pregnant or breastfeeding women, or women planning pregnancy within the next 6 months. 11) Individuals with hypersensitivity to the test product or any of its ingredients, or with known allergies to specific components. 12) Individuals who participated in another clinical trial or human study within 3 months prior to enrollment. 13) Any other individuals deemed unsuitable for participation by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| bowel movement frequency | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel habits;Quality of life;Microbiome and Metabolie analysis;Other bowel-related questionnaires | — |
Countries
Korea, Republic of
Contacts
Public ContactHyo Je Ahn
Korea Biomedical Research Institute
Outcome results
None listed