Ulcerative ColitisPhase 4NCT04969679
Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment.
A Phase 4 study testing E. coli Nissle 1917 (Mutaflor®) in people with Ulcerative Colitis, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- E. coli Nissle 1917 (Mutaflor®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2018to 3 Jun 2020
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-ASA (Mayo score 3-9)
- Patient who signed the consent form
Who cannot join
- The extent of ulcerative colitis is limited to proctitis
- History of bowel resection
- History of using other medication than 5-ASA such as immunomodulators, steroid or biologics within 3months
- history of using antibiotics or probiotics within 2 weeks
- Pregnant or lactating woman
- Requiring hospitalization and imminent need for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.
E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.
Read the detailed description
This is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC.
Subjects were randomly assigned to receive either E.coli Nissle 1917 (Mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared.
- Conditions
- Ulcerative Colitis
- Being tested
- E. coli Nissle 1917 (Mutaflor®), Placebo
- Keywords
- Mutaflor
- Medical subject headings
- Colitis, Ulcerative
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
Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks)
PlaceboDrug
Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| E. coli Nissle 1917 (Mutaflor®) | Active comparator | Active group will receive E. coli Nissle 1917 (Mutaflor®). Receives: Drug: E. coli Nissle 1917 (Mutaflor®) |
| Placebo | Placebo comparator | Placebo group will receive placebo drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group
The evaluation of the beneficial effects of Mutaflor on mild-to-moderate UC patients, was assessed by an increase in the IBDQ score more than 16 points from baseline to week 8.
The Score can range from 32 to 224, with higher scores reflecting better HRQOL(Health-related quality of life)
Measured: 8weeks
Secondary outcomes (5)
Evaluate the clinical remission between Mutaflor group and Placebo group
Partial Mayo≤1, assessed at week 4 or Mayo≤2, assessed at week 8. Mayo score can range from 0-12 with higher scores indicating worse severity.
Measured: 4weeks, 8weeks
Evaluate the clinical response between Mutaflor group and Placebo group
Partial Mayo≤2 or decrease more than 2 points, assessed at week 4 or Mayo≤ 2 or decrease more than 2 points, assessed at week 8.
Mayo score can range from 0-12 with higher scores indicating worse severity.
Measured: 4weeks, 8weeks
Improvement in endoscopic scores between Mutaflor group and Placebo group
Assessed by the endoscopic subgroup score=0 of the mayo. Mayo Endoscopic Sub Scores can range from 0-3, with higher scores indicating worse severity.
Measured: 8weeks
Evaluate the endoscopic response between Mutaflor group and Placebo group
Assessed by the endoscopic subgroup score=0 or decrease more than 1 point. Mayo Endoscopic Sub Scores can range from 0-3 with higher scores indicating worse severity.
Measured: 8weeks
Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group
Stool microbial change including diversity. DNA extraction from stool samples and 16S rRNA gene sequencing analysis. calculating α- and β-diversities.
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start16 Mar 2018
- Primary completion3 Jun 2020
- Study completion3 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-kyung Park, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969679
- Sponsor's protocol ID
- MUTAUC01
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park SK, Kang SB, Kim S, Kim TO, Cha JM, Im JP, Choi CH, Kim ES, Seo GS, Eun CS, Han DS, Park DI. Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis. Korean J Intern Med. 2022 Sep;37(5):949-957. doi: 10.3904/kjim.2021.458. Epub 2022 Mar 31.
PubMed 36068716
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment.
- ClinicalTrials.gov ID
- NCT04969679
- Acronym / sponsor ID
- MUTAUC01
- Conditions
- Ulcerative Colitis
- Keywords
- Mutaflor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 3 Jun 2020 (actual)
- Study completion
- 3 Jun 2020 (actual)
- First posted
- 21 Jul 2021 (actual)
- 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.
E.coli Nissle 1917 (Mutaflor®) is equivalent to mesalazine in preventing disease relapse in ulcerative colitis. However, data on ability of E.coli Nissle 1917 (Mutaflor®) to induce remission compared with placebo is limited. Investigators aim to investigate the efficacy of E.coli Nissle 1917 (Mutaflor®) as an add-on treatment to 5-ASA in mild to moderate ulcerative colitis.
Detailed description
This is a multicentre, double-blind, randomised, placebo-controlled study in patients with mild-to-moderate UC.
Subjects were randomly assigned to receive either E.coli Nissle 1917 (Mutaflor®) or placebo once daily for 8 weeks, and inflammatory bowel disease questionnaire (IBDQ) scores, clinical remission, and response rate were compared.
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®)Active group will receive E. coli Nissle 1917 (Mutaflor®). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group will receive placebo drug. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ulcerative colitis patients over the age of 19 with mild to moderate symptoms using 5-ASA (Mayo score 3-9)
- Patient who signed the consent form
Key exclusion criteria (6 listed)
- The extent of ulcerative colitis is limited to proctitis
- History of bowel resection
- History of using other medication than 5-ASA such as immunomodulators, steroid or biologics within 3months
- history of using antibiotics or probiotics within 2 weeks
- Pregnant or lactating woman
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®)Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks) | Drug | E. coli Nissle 1917 (Mutaflor®) |
| PlaceboTake 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks) | Drug | Placebo |
Primary outcome
Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group
Time frame: 8weeks
The evaluation of the beneficial effects of Mutaflor on mild-to-moderate UC patients, was assessed by an increase in the IBDQ score more than 16 points from baseline to week 8. The Score can range from 32 to 224, with higher scores reflecting better HRQOL(Health-related quality of life)
5 secondary outcomes
Evaluate the clinical remission between Mutaflor group and Placebo group
Time frame: 4weeks, 8weeks
Evaluate the clinical response between Mutaflor group and Placebo group
Time frame: 4weeks, 8weeks
Improvement in endoscopic scores between Mutaflor group and Placebo group
Time frame: 8weeks
Evaluate the endoscopic response between Mutaflor group and Placebo group
Time frame: 8weeks
Evaluate the Microbiome(stool) change between Mutaflor group and Placebo group
Time frame: 8weeks
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 21 Jul 2021.
- Derived from this study: PubMed 36068716Park SK, Kang SB, Kim S, Kim TO, Cha JM, Im JP, Choi CH, Kim ES, Seo GS, Eun CS, Han DS, Park DI. Additive effect of probiotics (Mutaflor) on 5-aminosalicylic acid therapy in patients with ulcerative colitis. Korean J Intern Med. 2022 Sep;37(5):949-957. doi: 10.3904/kjim.2021.458. Epub 2022 Mar 31.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ulcerative Colitis, run by Kangbuk Samsung Hospital 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 2 inclusion and 6 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 21 Jul 2021. 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?
Compare and evaluate the increase in IBDQ(Inflammatory bowel disease questionnaire) score between the Mutaflor group and the Placebo group (time frame: 8weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969679, which also lists 1 linked publication.
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 21 Jul 2021.