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

Irritable Bowel Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088971
• Other study ID #: CellBiotech
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2010
• Last updated: December 22, 2011
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: Cell Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Duolac7S
1 capsule two times everyday for 6 weeks
• starch
1capsule two times everyday for 6 weeks

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cell Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 weeks (symptom diary and weekly questionnaire)
Secondary	Changes in fecal microflora		baseline and after 6weeks
Secondary	Changes of biochemical marker		baseline and after 6weeks