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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

March 7, 2010
December 22, 2011
October 2009
July 2011   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01088971 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Dietary Supplement: Duolac7S
    1 capsule two times everyday for 6 weeks
  • Dietary Supplement: starch
    1capsule two times everyday for 6 weeks
  • Active Comparator: Duolac 7S
    Intervention: Dietary Supplement: Duolac7S
  • Placebo Comparator: starch capsule
    Intervention: Dietary Supplement: starch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01088971
CellBiotech
Not Provided
Cell Biotech Co., Ltd.
Cell Biotech Co., Ltd.
Not Provided
Not Provided
Cell Biotech Co., Ltd.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP