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

Cell Biotech

Status and phase

Completed

Phase 3

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: Duolac7S

Dietary Supplement: starch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01088971

CellBiotech

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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