Trial | NCT01088971  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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 Started
Oct 31
2009
Primary Completion
Jul 31
2011
Study Completion
Jul 31
2011
Last Update
Dec 23
2011
Estimate

Dietary Supplement Duolac7S

1 capsule two times everyday for 6 weeks

Dietary Supplement starch

1capsule two times everyday for 6 weeks

Duolac 7S Active Comparator

starch capsule Placebo Comparator

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
No Results Posted