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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Duolac7S
starch
Sponsored by
Cell Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yonsei University College of Medicine, Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Duolac 7S

starch capsule

Arm Description

Outcomes

Primary Outcome Measures

The improvement of IBS symptoms
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
Changes of biochemical marker

Full Information

First Posted
March 7, 2010
Last Updated
December 22, 2011
Sponsor
Cell Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01088971
Brief Title
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cell Biotech Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duolac 7S
Arm Type
Active Comparator
Arm Title
starch capsule
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Duolac7S
Intervention Description
1 capsule two times everyday for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
starch
Intervention Description
1capsule two times everyday for 6 weeks
Primary Outcome Measure Information:
Title
The improvement of IBS symptoms
Description
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).
Time Frame
6 weeks (symptom diary and weekly questionnaire)
Secondary Outcome Measure Information:
Title
Changes in fecal microflora
Time Frame
baseline and after 6weeks
Title
Changes of biochemical marker
Time Frame
baseline and after 6weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Yonsei University College of Medicine, Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of

12. IPD Sharing Statement

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

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