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

Primary Purpose

Constipation

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

E. coli Nissle 1917(Mutaflor®)

Placebo

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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:

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.

Sites / Locations

Yoo Jin Lee

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

E. coli Nissle 1917 (Mutaflor®)

Matched placebo

Arm 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.

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®).

Outcomes

Primary Outcome Measures

Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)

Subjects will report symptoms by questionnaire

Secondary Outcome Measures

Improvement of average number of CSBMs/week

Subjects will report symptoms by questionnaire

The time to 1st CSBM or SBM

Subjects will report symptoms by questionnaire

Improvement of constipation related quality of life

Subjects will report symptoms by questionnaire

Improvement of constipation related symptom

Subjects will report symptoms by questionnaire

Full Information

NCT ID

NCT02726295

First Posted

March 29, 2016

Last Updated

October 2, 2017

Sponsor

Keimyung University Dongsan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02726295

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Keimyung University Dongsan Medical Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E. coli Nissle 1917 (Mutaflor®)

Arm Type

Active Comparator

Arm 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.

Arm Title

Matched placebo

Arm Type

Placebo Comparator

Arm 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®).

Intervention Type

Drug

Intervention Name(s)

E. coli Nissle 1917(Mutaflor®)

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)

Description

Subjects will report symptoms by questionnaire

Time Frame

28days

Secondary Outcome Measure Information:

Title

Improvement of average number of CSBMs/week

Description

Subjects will report symptoms by questionnaire

Time Frame

28days

Title

The time to 1st CSBM or SBM

Description

Subjects will report symptoms by questionnaire

Time Frame

28days

Title

Improvement of constipation related quality of life

Description

Subjects will report symptoms by questionnaire

Time Frame

28days

Title

Improvement of constipation related symptom

Description

Subjects will report symptoms by questionnaire

Time Frame

28days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoo Jin Lee, Professor

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jung Eun Shin, Professor

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Yoo Jin Lee

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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