The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.

Official Title
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The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial

Conditions
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Diarrhea Predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Multi-strain probiotics
* Drug: Placebo powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willing to consent/undergo necessary procedures between the age of 19 and 75 years diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria) Exclusion Criteria: uncontrolled hypertension (Blood pressure > 180/110 mmHg) uncontrolled diabetes mellitus (FBS > 200 mg/dL) malignancy, cerebrovascular disease, cardiovascular disease history of abdominal surgery except appendectomy and hernia repair inflammatory bowel disease clinically or laboratory-confirmed gastroenteritis the use of motility drug or dietary fiber supplement in 2 weeks serum Cr > 2 x Upper normal limit AST or ALT > 2 x Upper normal limit Pregnancy, Lactating woman

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-strain probiotics<br> | Drug: Multi-strain probiotics<br>* B. longum BORI: 1 x 109 B. bifidum BGN4: 1 x 109 B. lactis AD011: 1 x 109 B. infantis IBS007: 1 x 109 Lactobacillus acidophilus AD031: 1 x 109 three times a day, within 10 minutes after meal, per oral with water<br>|
| Placebo Comparator: Placebo powder<br> | Drug: Placebo powder<br>* same taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of Irritable bowel syndrome symptom severity score (IBS-SSS) | Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life | after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency and form | Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool) | after 4 weeks and 8 weeks | 
| Symptom control of irritable bowel syndrome |  | after 4 weeks and 8 weeks | 
| Improvement of overall symptom in patient with irritable bowel syndrome |  | after 4 weeks and 8 weeks | 
| Assessment for quality of life related with irritable bowel syndrome |  | after 4 weeks and 8 weeks | 
| Assessment for patient satisfaction after administration completion |  | after 4 weeks and 8 weeks |