ConstipationPhase 4NCT02726295
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
A Phase 4 study testing E. coli Nissle 1917(Mutaflor®) in people with Constipation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- E. coli Nissle 1917(Mutaflor®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female outpatients aged from 20 to 75 years old.
- Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- E. coli Nissle 1917(Mutaflor®), Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli Nissle 1917(Mutaflor®)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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®). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)
Subjects will report symptoms by questionnaire
Measured: 28days
Secondary outcomes (4)
Improvement of average number of CSBMs/week
Subjects will report symptoms by questionnaire
Measured: 28days
The time to 1st CSBM or SBM
Subjects will report symptoms by questionnaire
Measured: 28days
Improvement of constipation related quality of life
Subjects will report symptoms by questionnaire
Measured: 28days
Improvement of constipation related symptom
Subjects will report symptoms by questionnaire
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YooJin Lee, Keimyung University Dongsan Medical Center
- Investigators
- Yoo Jin Lee, Professor, Principal investigator, 56 Dalseong-Ro, Jung-Gu, Daegu, KoreaJung Eun Shin, Professor, Study director, Dankook Univ. Hospotal (31116) 201 Manghyang-ro, Dongnam-gu, Cheonan, Chung Nam, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726295
- Sponsor's protocol ID
- 2015-11-044-002
- Status last verified
- Oct 2017
- First submitted
- 29 Mar 2016
- Last updated
- 3 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
- ClinicalTrials.gov ID
- NCT02726295
- Acronym / sponsor ID
- 2015-11-044-002
- Conditions
- Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E. coli Nissle 1917 (Mutaflor®) | Active comparator | Drug: 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 comparator | Drug: PlaceboMatched 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®). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult male or female outpatients aged from 20 to 75 years old.
- Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:
- Must include two or more of the following:
- Straining in > 1/4 defecations;
- Lumpy or hard stools > 1/4 defecations;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E. coli Nissle 1917(Mutaflor®) | Drug | E. coli Nissle 1917 (Mutaflor®) |
| Placebo | Drug | Matched placebo |
Primary outcome
Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week)
Time frame: 28days
Subjects will report symptoms by questionnaire
4 secondary outcomes
Improvement of average number of CSBMs/week
Time frame: 28days
The time to 1st CSBM or SBM
Time frame: 28days
Improvement of constipation related quality of life
Time frame: 28days
Improvement of constipation related symptom
Time frame: 28days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoo Jin Lee, Professor principal investigator
56 Dalseong-Ro, Jung-Gu, Daegu, Korea
Jung Eun Shin, Professor study director
Dankook Univ. Hospotal (31116) 201 Manghyang-ro, Dongnam-gu, Cheonan, Chung Nam, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E. coli Nissle 1917(Mutaflor®) in people with Constipation, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of constipation defined by improvement of complete spontaneous bowel movements(CSBMs/week) (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2017.