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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
1 capsule two times everyday for 6 weeks
1capsule two times everyday for 6 weeks
Yonsei University College of Medicine, Gangnam Severance Hospital
Seoul, Seoul, South Korea
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).
Time frame: 6 weeks (symptom diary and weekly questionnaire)
Changes in fecal microflora
Time frame: baseline and after 6weeks
Changes of biochemical marker
Time frame: baseline and after 6weeks
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