- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088971
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
December 22, 2011 updated by: Cell Biotech Co., Ltd.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135-720
- Yonsei University college of Medicine, Gangnam Severance Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age: 18~65 years
- diarrhea type irritable bowel syndrome (by ROME III criteria)
- no organic bowel disease (by colonoscopy or barium enema)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Duolac 7S
|
1 capsule two times everyday for 6 weeks
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Placebo Comparator: starch capsule
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1capsule two times everyday for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The improvement of IBS symptoms
Time Frame: 6 weeks (symptom diary and weekly questionnaire)
|
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).
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6 weeks (symptom diary and weekly questionnaire)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in fecal microflora
Time Frame: baseline and after 6weeks
|
baseline and after 6weeks
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Changes of biochemical marker
Time Frame: baseline and after 6weeks
|
baseline and after 6weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
March 7, 2010
First Submitted That Met QC Criteria
March 16, 2010
First Posted (Estimate)
March 18, 2010
Study Record Updates
Last Update Posted (Estimate)
December 23, 2011
Last Update Submitted That Met QC Criteria
December 22, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CellBiotech
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
-
ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
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University of ViennaCompleted
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Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on Duolac7S
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Korea Institute of Planning & Evalution for Technology...CompletedHealthyKorea, Republic of
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Kyunghee University Medical CenterCompletedEffect of Herbal Extract Granules Combined With Probiotics on Irritable Bowel Syndrome With DiarrheaIrritable Bowel SyndromeKorea, Republic of