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

NCT ID: NCT02726295

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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E. coli Nissle 1917 (Mutaflor®)

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.

Group Type ACTIVE_COMPARATOR

E. coli Nissle 1917(Mutaflor®)

Intervention Type DRUG

Matched placebo

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®).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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E. coli Nissle 1917(Mutaflor®)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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YooJin Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoo Jin Lee, Professor

Role: PRINCIPAL_INVESTIGATOR

56 Dalseong-Ro, Jung-Gu, Daegu, Korea

Jung Eun Shin, Professor

Role: STUDY_DIRECTOR

Dankook Univ. Hospotal (31116) 201 Manghyang-ro, Dongnam-gu, Cheonan, Chung Nam, South Korea

Locations

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Yoo Jin Lee

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2015-11-044-002

Identifier Type: -

Identifier Source: org_study_id