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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01088971
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : December 23, 2011
Information provided by (Responsible Party):
Cell Biotech Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Duolac7S Dietary Supplement: starch Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Active Comparator: Duolac 7S Dietary Supplement: Duolac7S
1 capsule two times everyday for 6 weeks

Placebo Comparator: starch capsule Dietary Supplement: starch
1capsule two times everyday for 6 weeks

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. Changes in fecal microflora [ Time Frame: baseline and after 6weeks ]
  2. Changes of biochemical marker [ Time Frame: baseline and after 6weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01088971

Korea, Republic of
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Sponsors and Collaborators
Cell Biotech Co., Ltd.

Responsible Party: Cell Biotech Co., Ltd. Identifier: NCT01088971     History of Changes
Other Study ID Numbers: CellBiotech
First Posted: March 18, 2010    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases