None listed
Conditions
Interventions
Dietary Supplement : Participants will consume the assigned investigational product (IP) once daily for 6 weeks according to their randomized group allocation.
Intervention group: Receives Heat-kille
Sponsors
Mediogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Man and women aged 19 to 70 years. 2) Individuals whose symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D) began at least 6 months prior to Visit 1, who have experienced symptoms at least once per week on average during the 3 months prior to Visit 1, and who meet at least two of the Rome IV diagnostic criteria for IBS-D. 3) Individuals who voluntarily agree to participate in the study and sign the Informed Consent Form (ICF) prior to the start of the human intervention study.
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal/urinary, neurologic, endocrine, psychiatric, infectious diseases, or malignant tumors. 2) Individuals with organic diseases of the small or large intestine, or other conditions that may affect gastrointestinal motility (e.g., inflammatory bowel disease, malabsorption, lactose intolerance), except for benign colon polyps. 3) Individuals with a history of drug abuse. 4) Individuals with a history of alcohol abuse or those who consume alcohol equivalent to =40 g/day for men (=280 g/week) or =20 g/day for women (=140 g/week). 5) Individuals with a history of small or large bowel surgery (appendectomy, hernia repair, and cholecystectomy are allowed). 6) Individuals diagnosed within the past 2 years (based on Visit 1) with gastrointestinal diseases of known cause (e.g., Crohn’s disease, celiac disease, ulcerative colitis, colorectal cancer). 7) Individuals who used the following medications or health functional foods within 4 weeks prior to Visit 1: ? Medications that may affect IBS symptoms ? Systemic antibiotics, systemic antimicrobials, intestinal regulators, antidiarrheals, antispasmodics, laxatives ? Probiotics, prebiotics, or lactic acid bacteria products consumed regularly (=4 days per week) 8) Individuals who consumed health functional foods that may affect bowel habits within 2 weeks prior to Visit 1. 9) Individuals with rectal bleeding or those who experienced =10% unintentional weight loss within 6 months prior to Visit 1. 10) Individuals with AST (GOT) or ALT (GPT) levels =3 times the upper limit of normal. 11) Individuals with creatinine levels >2.0 mg/dL. 12) Individuals with uncontrolled diabetes (HbA1c =7.0%). 13) Individuals with an ESR >30 mm/hr. 14) Individuals with a CRP >2.0 mg/dL. 15) Individuals with abnormal dietary habits or with significant dietary changes within 4 weeks prior to Visit 1 (e.g., strict vegetarian diet). 16) Pregnant or breastfeeding women, or women planning to become pregnant during the study period. 17) Individuals who participated in another interventional clinical study within 3 months prior to Visit 1, or who plan to participate in another interventional study during this trial. 18) Individuals with known hypersensitivity or allergy to any component of the investigational product (test or placebo). 19) Individuals who, for any other reason, are judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool frequency and form | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal discomfort;Irritable Bowel Syndrome_Symptom Severity Score (IBS-SSS);Irritable Bowel Syndrome_Quality of Life (IBS-QOL);Cytokine: Interleukin-6 (IL-6), Interleukin-8 (IL-8), Interleukin-10 (IL-10);Fecal microbiome analysis | — |
Countries
Korea, Republic of
Contacts
Public ContactMun-cheol Lee
Bestian Seoul Hospital
Outcome results
None listed