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

This study is currently recruiting participants.
Verified June 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01637714
First received: June 21, 2012
Last updated: June 17, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition Intervention
Diarrhea Predominant Irritable Bowel Syndrome
 Drug: Multi-strain probiotics
Drug: Placebo powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of Irritable bowel syndrome symptom severity score (IBS-SSS) [ Time Frame: after 8 weeks ] [ Designated as safety issue: Yes ]
    Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life


Secondary Outcome Measures:
  • Stool frequency and form [ Time Frame: after 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]
    Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)

  • Symptom control of irritable bowel syndrome [ Time Frame: after 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]
  • Improvement of overall symptom in patient with irritable bowel syndrome [ Time Frame: after 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]
  • Assessment for quality of life related with irritable bowel syndrome [ Time Frame: after 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]
  • Assessment for patient satisfaction after administration completion [ Time Frame: after 4 weeks and 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637714

Contacts
Contact: Joo Sung Kim, M.D., PhD +82-2-740-8112 jooskim@snu.ac.kr
Contact: Kyoung Sup Hong, M.D. +82-10-2578-5738 kshong1@empas.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Joo Sung Kim, M.D.,PhD     +82-2-740-8112     jooskim@snu.ac.kr    
Contact: Kyoung Sup Hong, M.D.     +82-10-2578-5738     kshong1@empas.com    
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Joo Sung Kim, M.D.,PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01637714     History of Changes
Other Study ID Numbers: Probiotics for IBS
Study First Received: June 21, 2012
Last Updated: June 17, 2013
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013