The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome
1 other identifier
interventional
70
1 country
1
Brief Summary
The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJune 18, 2013
June 1, 2013
1 year
June 21, 2012
June 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Stool frequency and form
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
Study Arms (2)
Multi-strain probiotics
EXPERIMENTALPlacebo powder
PLACEBO COMPARATORInterventions
* 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
same taste, shape, dosage as experimental drug three times a day, within 10 minutes after meal, per oral with water
Eligibility Criteria
You may qualify if:
- willing to consent/undergo necessary procedures
- between the age of 19 and 75 years
- diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Joo Sung Kim, M.D.,PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
July 11, 2012
Study Start
July 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
June 18, 2013
Record last verified: 2013-06