Back to resultsThe Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
Primary Purpose
Diarrhea Predominant Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multi-strain probiotics
Placebo powder
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea Predominant Irritable Bowel Syndrome
Eligibility 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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Multi-strain probiotics
Placebo powder
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Symptom control of irritable bowel syndrome
Improvement of overall symptom in patient with irritable bowel syndrome
Assessment for quality of life related with irritable bowel syndrome
Assessment for patient satisfaction after administration completion
Full Information
NCT ID
NCT01637714
First Posted
June 21, 2012
Last Updated
June 17, 2013
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01637714
Brief Title
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
Official Title
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
5. Study Description
Brief Summary
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Predominant Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multi-strain probiotics
Arm Type
Experimental
Arm Title
Placebo powder
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Multi-strain probiotics
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo powder
Intervention Description
same taste, shape, dosage as experimental drug
three times a day, within 10 minutes after meal, per oral with water
Primary Outcome Measure Information:
Title
change of Irritable bowel syndrome symptom severity score (IBS-SSS)
Description
Severity and frequency of abdominal pain / abdominal bloating / bowel habitus / interfere degree of daily life
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
Stool frequency and form
Description
Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)
Time Frame
after 4 weeks and 8 weeks
Title
Symptom control of irritable bowel syndrome
Time Frame
after 4 weeks and 8 weeks
Title
Improvement of overall symptom in patient with irritable bowel syndrome
Time Frame
after 4 weeks and 8 weeks
Title
Assessment for quality of life related with irritable bowel syndrome
Time Frame
after 4 weeks and 8 weeks
Title
Assessment for patient satisfaction after administration completion
Time Frame
after 4 weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Sung Kim, M.D., PhD
Phone
+82-2-740-8112
Email
jooskim@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Kyoung Sup Hong, M.D.
Phone
+82-10-2578-5738
Email
kshong1@empas.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Sung Kim, M.D.,PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Sung Kim, M.D.,PhD
Phone
+82-2-740-8112
Email
jooskim@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyoung Sup Hong, M.D.
Phone
+82-10-2578-5738
Email
kshong1@empas.com
12. IPD Sharing Statement
Learn more about this trial
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
We'll reach out to this number within 24 hrs