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

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Duolac7S; Dietary Supplement: starch

• Registration Number: NCT01088971
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-03-07
• Study First Submitted QC: 2010-03-16
• Study First Posted: 2010-03-18
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-22
• Last Update Posted: 2011-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duolac 7S	Duolac7S	-
starch capsule	starch	-

Primary Outcome Measures

Name	Time	Method
The improvement of IBS symptoms	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

Name	Time	Method
Changes in fecal microflora	baseline and after 6weeks
Changes of biochemical marker	baseline and after 6weeks

Trial Locations

Locations (1)

Yonsei University College of Medicine, Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of