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

June 17, 2013 updated by: Seoul National University Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: after 8 weeks
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
Time Frame: 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)
after 4 weeks and 8 weeks
Symptom control of irritable bowel syndrome
Time Frame: after 4 weeks and 8 weeks
after 4 weeks and 8 weeks
Improvement of overall symptom in patient with irritable bowel syndrome
Time Frame: after 4 weeks and 8 weeks
after 4 weeks and 8 weeks
Assessment for quality of life related with irritable bowel syndrome
Time Frame: after 4 weeks and 8 weeks
after 4 weeks and 8 weeks
Assessment for patient satisfaction after administration completion
Time Frame: after 4 weeks and 8 weeks
after 4 weeks and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Probiotics for IBS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diarrhea Predominant Irritable Bowel Syndrome

Clinical Trials on Multi-strain probiotics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe