Kimchi Powder on Gut Health
ConditionIrritable Bowel Syndrome - Diarrhoea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorPusan National University Yangsan Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Kimchi power
Dietary supplementKimchi 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
Dietary supplementPlacebo 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: This group takes Kimchi power for 8 weeks.Experimental treatment 1 intervention
Group B: This group takes placebo power for 8 weeks.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in IBS Severity Scoring System (IBS-SSS) total score
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.
Time frame
Baseline (Day 0) and Week 8 (Day 56 +/- 7)Secondary outcomes
1
Change in stool form measured by the Bristol Stool Form Scale
Stool form is classified using the Bristol Stool Form Scale, a 7-point pictorial scale ranging from type 1 (separate hard lumps) to type 7 (entirely liquid). Types 6 and 7 represent loose or watery stool characteristic of diarrhea-predominant irritable bowel syndrome, and types 3 to 4 are considered normal. Change is calculated as the Week 8 value minus the baseline value. The value obtained at screening is used as the baseline value.
Time frame
Baseline (Day 0) and Week 8 (Day 56 +/- 7)2
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
The IBS-QOL questionnaire consists of 34 items rated on a 5-point Likert scale, covering dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual function, and relationships. The summed score is transformed to a 0 to 100 scale. Higher scores indicate better disease-specific quality of life, so a positive change indicates improvement.
Time frame
Baseline (Day 0), Week 3 (Day 21 +/- 7), and Week 8 (Day 56 +/- 7)3
Change in Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS) score
The VAS-IBS assesses bowel symptoms including abdominal pain, diarrhea, constipation, bloating and flatulence, vomiting and nausea, psychological well-being, and intestinal symptoms' influence on daily life, each rated on a 100 mm visual analogue scale. Higher scores indicate less severe symptoms, so a positive change indicates improvement. Change is calculated as the Week 8 value minus the baseline value.
Time frame
Baseline (Day 0) and Week 8 (Day 56 +/- 7)4
Change in defecation symptom assessment (frequency of diarrhea)
Frequency of diarrheal bowel movements is recorded as the number of episodes per week. Change is calculated as the Week 8 value minus the baseline value, with a negative change indicating improvement.
Time frame
Baseline (Day 0) and Week 8 (Day 56 +/- 7)Sponsors and contacts
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Source ClinicalTrials.gov