Kimchi powder for gut health in adults with IBS-D

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial examines the effects of kimchi powder supplementation on gut health in adults with IBS-D. Participants will be randomly assigned to kimchi powder or placebo for 8 weeks, with outcomes focused on gut-related measures. The study builds on the idea that fermented foods contain bioactive compounds and live microbes that may influence the gut microbiome and function. Eligibility includes adults 20 to 70 with IBS-D and BMI 25–30, who agree to avoid kimchi-containing foods during the study. Primary results will inform whether kimchi powder can be a feasible dietary approach to support gut health in IBS-D.

Why it matters

Who can join: the full rules

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

Where it's running

• Pusan National University Yangsan Hospital
  Yangsan, South Korea Recruiting

Study contacts

• Principal investigator: Sang Yeoup Lee, MD, PhD — Pusan National University Yangsan Hospital
• Study coordinator: Professor
• Email: drsaylee@gmail.com
• Phone: +82-55-360-2860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.