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

NCT02726295 | Completed Phase 4

• 1 other identifier: 2015-11-044-002
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

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

  Subjects will report symptoms by questionnaire

  28days

Secondary Outcomes (4)

• Improvement of average number of CSBMs/week

  28days

• The time to 1st CSBM or SBM

  28days

• Improvement of constipation related quality of life

  28days

• Improvement of constipation related symptom

  28days

Study Arms (2)

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

E. coli Nissle 1917(Mutaflor®) DRUG

E. coli Nissle 1917 (Mutaflor®)

Placebo DRUG

Matched placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keimyung University Dongsan Medical Center: lead

Study Sites (1)

Yoo Jin Lee

Daegu, 700-712, South Korea

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 1, 2016
• Study Start: September 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-10

Locations

KR (1)