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

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

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

Study Overview

• Status: Unknown
• Conditions: Diarrhea Predominant Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Multi-strain probiotics; Drug: Placebo powder

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joo Sung Kim, M.D., PhD; Phone Number: +82-2-740-8112; Email: jooskim@snu.ac.kr
• Study Contact Backup: Name: Kyoung Sup Hong, M.D.; Phone Number: +82-10-2578-5738; Email: kshong1@empas.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Kyoung Sup Hong, M.D.; Phone Number: +82-10-2578-5738; Email: kshong1@empas.com
    • Contact: Joo Sung Kim, M.D.,PhD; Phone Number: +82-2-740-8112; Email: jooskim@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-strain probiotics	Drug: Multi-strain probiotics; 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
Placebo Comparator: Placebo powder	Drug: Placebo powder; same taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Joo Sung Kim, M.D.,PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: July 8, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): June 18, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: Probiotics for IBS