Kimchi power: Kimchi powder in capsule form, 3,000 mg/day of kimchi powder (total 3,600 mg/day as capsules), taken orally in three divided doses after meals for 8 weeks.
Placebo: Placebo capsules identical in appearance and packaging to the test product, containing lactose and other excipients, total 3,600 mg/day, taken orally in three divided doses after meals for 8 weeks.
Study summary
The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Kimchi powder supplementation on gut health in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) for 8 weeks.
Eligibility
Sex
ALL
Min age
20 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* Adults, male or female, aged 20 to 70 years
* Body mass index of 25 kg/m2 or more and less than 30 kg/m2
* Meeting the Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D), defined as Bristol Stool Form Scale type 6 or 7 in 25% or more of bowel movements from 2 weeks before screening through the day of the screening visit
* No inflammatory bowel disease or malignancy
* Provided written agreement to refrain from consuming kimchi-containing foods for the duration of the study (approximately 2 months)
Exclusion Criteria:
* Drug-induced constipation
* Constipation secondary to another condition, such as diabetes mellitus or thyroid disease
* History of intra-abdominal surgery other than appendectomy (including gastrectomy, gastric bypass, gallbladder or biliary tract surgery, pancreatectomy, bowel resection with particular reference to the ileum, and colorectal surgery or insertion procedures)
* Uncontrolled hypertension (resting blood pressure 160/100 mmHg or higher)
* Uncontrolled diabetes mellitus (fasting blood glucose 160 mg/dL or higher)
* Uncontrolled hypothyroidism or hyperthyroidism
* AST or ALT concentration 3 times or more the upper limit of the reference range of the testing laboratory
* Creatinine concentration 2 times or more the upper limit of the reference range of the testing laboratory
* Severe cardiovascular or cerebrovascular disease or malignancy within the previous 6 months
* Psychiatric disorder such as severe affective disorder, schizophrenia, or substance use disorder, or current use of related psychiatric medication (intermittent use for sleep disturbance is permitted)
* Severe alcohol use disorder
* Heavy smoking (20 cigarettes per day or more)
* Hypersensitivity to the main ingredient or components of the study food
* Severe gastrointestinal symptoms such as heartburn or dyspepsia
* Use of medications or foods that may affect the study results, including kimchi and probiotics
* For female volunteers, suspected pregnancy, lactation, or plan to become pregnant during the study period
* Participation in another drug clinical trial within one month prior to the screening date, or planned participation
* Judged unsuitable for participation by the principal investigator for reasons other than those listed above
Primary outcome measure(s)
Change in IBS Severity Scoring System (IBS-SSS) total score — Baseline (Day 0) and Week 8 (Day 56 +/- 7) The IBS Severity Scoring System (IBS-SSS) consists of five items assessing severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life. Each item is scored on a 100-point visual analogue scale, giving a total score ranging from 0 to 500. Higher scores indicate more severe symptoms; scores below 75 indicate remission, 75 to 175 mild, 175 to 300 moderate, and above 300 severe irritable bowel syndrome. Change is calculated as the Week 8 value minus the baseline value, with a negative change indicating improvement.
Trial sites (1)
Facility
City
Region
Status
Pusan National University Yangsan Hospital
Yangsan
South Korea
Recruiting
More Pusan National University Yangsan Hospital trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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