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

Phase 4

Completed

• Conditions: Constipation
• Interventions: Drug: E. coli Nissle 1917(Mutaflor®); Drug: Placebo

• Registration Number: NCT02726295
• Lead Sponsor: Keimyung University Dongsan Medical Center

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 available

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-01
• Study Start: 2016-09
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E. coli Nissle 1917 (Mutaflor®)	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.
Matched placebo	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®).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement of average number of CSBMs/week	28days	Subjects will report symptoms by questionnaire
Improvement of constipation related symptom	28days	Subjects will report symptoms by questionnaire
The time to 1st CSBM or SBM	28days	Subjects will report symptoms by questionnaire
Improvement of constipation related quality of life	28days	Subjects will report symptoms by questionnaire

Trial Locations

Locations (1)

Yoo Jin Lee; 🇰🇷 Daegu, Korea, Republic of