Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Cell Biotech Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01088971

First received: March 7, 2010

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 7, 2010
Last Updated Date	December 22, 2011
Start Date ^ICMJE	October 2009
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 16, 2010)	The improvement of IBS symptoms [ Time Frame: 6 weeks (symptom diary and weekly questionnaire) ] [ Designated as safety issue: No ] 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).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01088971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 16, 2010)	Changes in fecal microflora [ Time Frame: baseline and after 6weeks ] [ Designated as safety issue: No ] Changes of biochemical marker [ Time Frame: baseline and after 6weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Irritable Bowel Syndrome
Intervention ^ICMJE	Dietary Supplement: Duolac7S 1 capsule two times everyday for 6 weeks Dietary Supplement: starch 1capsule two times everyday for 6 weeks
Study Arm (s)	Active Comparator: Duolac 7S Intervention: Dietary Supplement: Duolac7S Placebo Comparator: starch capsule Intervention: Dietary Supplement: starch
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	July 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01088971
Other Study ID Numbers ^ICMJE	CellBiotech
Has Data Monitoring Committee	Not Provided
Responsible Party	Cell Biotech Co., Ltd.
Study Sponsor ^ICMJE	Cell Biotech Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Cell Biotech Co., Ltd.
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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