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
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: Duolac7S
Dietary Supplement: starch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Cell Biotech Co., Ltd.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: October 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088971

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

No publications provided

Responsible Party: Cell Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01088971     History of Changes
Other Study ID Numbers: CellBiotech
Study First Received: March 7, 2010
Last Updated: December 22, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014