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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

June 21, 2012
June 17, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01637714 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diarrhea Predominant Irritable Bowel Syndrome
  • 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

  • Drug: Placebo powder

    same taste, shape, dosage as experimental drug

    three times a day, within 10 minutes after meal, per oral with water
  • Experimental: Multi-strain probiotics
    Intervention: Drug: Multi-strain probiotics
  • Placebo Comparator: Placebo powder
    Intervention: Drug: Placebo powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
19 Years to 75 Years
Yes
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
Korea, Republic of
 
NCT01637714
Probiotics for IBS
Not Provided
Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Joo Sung Kim, M.D.,PhD Seoul National University Hospital
Seoul National University Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP