Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
This study has been completed.
Sponsor:
Cell Biotech Co., Ltd.
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
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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 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 May 16, 2013