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

Keimyung University

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: Placebo; Drug: E. coli Nissle 1917(Mutaflor®)

Study type: Interventional

Funder types: Other

Identifiers

NCT02726295

2015-11-044-002

Details and patient eligibility

About

Chronic constipation is a prevalent, burdensome gastrointestinal disorder whose treatment remains challenging. There exist effective pharmacological therapies for chronic constipation, however, many patients do not well respond to current medications. Evidence suggests that disturbance in the gastrointestinal microbiota may be implicated in chronic constipation. Although, E.coli Nissle 1917 (Mutaflor®) has been used for chronic constipation, there are limited data regarding the efficacy of E.coli Nissle 1917 (Mutaflor®) in these patients. Therefore, this study aimed to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) in patients with chronic constipation.

Enrollment: 112 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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:

1. Straining in > 1/4 defecations;
2. Lumpy or hard stools > 1/4 defecations;
3. Sensation of incomplete evacuation in 1/4 defecations;
4. Sensation of anorectal obstruction/blockage in > 1/4 defecations;
5. <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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

E. coli Nissle 1917 (Mutaflor®)

Active Comparator group

Description:

Mutaflor® group will receive E. coli Nissle 1917 (Mutaflor®) 28mg 2T tid for initial 2 days, then E. coli Nissle 1917, Mutaflor® 4T qd for the next 26 days.

Treatment:

Drug: E. coli Nissle 1917(Mutaflor®)

Matched placebo

Placebo Comparator group

Description:

Matched placebo group will receive placebo drug 28mg 2T tid for initial 2 days, then placebo 4T qd for the next 26 days. Placebo drug has same shape and size with E. coli Nissle 1917 (Mutaflor®).

Treatment:

Drug: Placebo