The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®)... | NCT02726295

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

NCT02726295

Sponsor

Keimyung University Dongsan Medical Center

Status

Completed

Last Update Posted

Oct 3, 2017Actual

Enrollment

112Actual

Phase

Phase 4

Conditions

Constipation

Interventions

E. coli Nissle 1917(Mutaflor®)
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Mar 29, 2016

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2017

Last Update Posted Date

Oct 3, 2017Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E. coli Nissle 1917 (Mutaflor®)	Active Comparator	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.	Drug: E. coli Nissle 1917(Mutaflor®)
Matched placebo	Placebo Comparator	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®).	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E. coli Nissle 1917(Mutaflor®)	Drug		E. coli Nissle 1917 (Mutaflor®)
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)	Subjects will report symptoms by questionnaire	28days

Secondary Outcomes

Measure	Description	Time Frame
Improvement of average number of CSBMs/week	Subjects will report symptoms by questionnaire	28days
The time to 1st CSBM or SBM	Subjects will report symptoms by questionnaire

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yoo Jin Lee, Professor	56 Dalseong-Ro, Jung-Gu, Daegu, Korea	Principal Investigator
Jung Eun Shin, Professor	Dankook Univ. Hospotal (31116) 201 Manghyang-ro, Dongnam-gu, Cheonan, Chung Nam, South Korea	Study Director

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms