Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
1 other identifier
interventional
60
1 country
1
Brief Summary
Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2009
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
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 7, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 23, 2011
December 1, 2011
1.7 years
March 7, 2010
December 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The improvement of IBS symptoms
IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7).
6 weeks (symptom diary and weekly questionnaire)
Secondary Outcomes (2)
Changes in fecal microflora
baseline and after 6weeks
Changes of biochemical marker
baseline and after 6weeks
Study Arms (2)
Duolac 7S
ACTIVE COMPARATORstarch capsule
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- age: 18\~65 years
- diarrhea type irritable bowel syndrome (by ROME III criteria)
- no organic bowel disease (by colonoscopy or barium enema)
You may not qualify if:
- pregnant women or nursing mothers
- hypersensitivity to probiotics
- congestive heart failure or ischemic heart disease
- systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
- uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
- abdominal surgery (exception: appendectomy, hernia surgery)
- more than moderate alcohol drinking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, Seoul, 135-720, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2010
First Posted
March 18, 2010
Study Start
October 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 23, 2011
Record last verified: 2011-12