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

Constipation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726295
• Other study ID #: 2015-11-044-002
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2016
• Last updated: October 2, 2017
• Start date: September 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• E. coli Nissle 1917(Mutaflor®)

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Yoo Jin Lee	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)	Subjects will report symptoms by questionnaire	28days
Secondary	Improvement of average number of CSBMs/week	Subjects will report symptoms by questionnaire	28days
Secondary	The time to 1st CSBM or SBM	Subjects will report symptoms by questionnaire	28days
Secondary	Improvement of constipation related quality of life	Subjects will report symptoms by questionnaire	28days
Secondary	Improvement of constipation related symptom	Subjects will report symptoms by questionnaire	28days