Clinical trial NCT02726295: The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)
timeFrame: 28days
Secondary outcomes:
measure: Improvement of average number of CSBMs/week
timeFrame: 28days
measure: The time to 1st CSBM or SBM
timeFrame: 28days
measure: Improvement of constipation related quality of life
timeFrame: 28days
measure: Improvement of constipation related symptom
timeFrame: 28days
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yoo Jin Lee
Study officials:
affiliation: 56 Dalseong-Ro, Jung-Gu, Daegu, Korea
name: Yoo Jin Lee, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dankook Univ. Hospotal (31116) 201 Manghyang-ro, Dongnam-gu, Cheonan, Chung Nam, South Korea
name: Jung Eun Shin, Professor
role: STUDY_DIRECTOR
References: