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

NCT02726295 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2017-10-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

E. coli Nissle 1917(Mutaflor®)

DRUG

Placebo

Sponsors & Collaborators

  • Keimyung University Dongsan Medical Center

    lead OTHER

Principal Investigators

  • Yoo Jin Lee, Professor · 56 Dalseong-Ro, Jung-Gu, Daegu, Korea

  • Jung Eun Shin, Professor · Dankook Univ. Hospotal (31116) 201 Manghyang-ro, Dongnam-gu, Cheonan, Chung Nam, South Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02726295 on ClinicalTrials.gov