The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study

Inclusion criteria

• Adult male or female outpatients aged from 20 to 75 years old.
• Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:

A. Must include two or more of the following:

• Straining in > 1/4 defecations;
• Lumpy or hard stools > 1/4 defecations;
• Sensation of incomplete evacuation in 1/4 defecations;
• Sensation of anorectal obstruction/blockage in > 1/4 defecations;
• <3 defecations/week.

B.Loose stools are rarely present without the use of laxatives. C.There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.

Exclusion criteria

• Pregnant or lactating woman
• Known organic gastrointestinal disease
• Subjects who diagnosed advanced adenoma within 3 years
• Prior gastrointestinal surgery (except appendectomy, herniotomy)
• Subjects who diagnosed irritable bowel syndrome
• Use of one or more of listed medications within 2 weeks (Laxative, Metoclopramide, Domperidone, Itopride, Levosulpride, Cisapride, Mosapride, Tegaserod, Prucalopride, Renzapride, Erythromycin, buspirone, Sumatriptan, Alosetron, Cilansetron, ondansetron, Citalopram, Paroxetine, Baclofen, Sildenafil, Nitroglycerin)
• Subjects who diagnosed lactulose malabsorption
• Subjects who diagnosed liver cirrhosis, severe congestive heart failure, severe renal insufficiency, uncontrolled hypertension, endocrine disorder, metabolic disorder, prior malignancy, immune deficiency
• Suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.