๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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