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

Not Applicable

• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Interventions: Drug: Placebo powder; Drug: Multi-strain probiotics

• Registration Number: NCT01637714
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-06-21
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-08
• Study First Posted: 2012-07-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18
• Primary Completion: 2013-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo powder	Placebo powder	-
Multi-strain probiotics	Multi-strain probiotics	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of