Ulcerative ColitisEMMENTALNCT02488954
Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
A study testing Probiotics in the form of cheese portion in people with Ulcerative Colitis, run by Rennes University Hospital at 1 site in France.
Trial summary
Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Probiotics in the form of cheese portion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2016to 30 Jun 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with age above 18 years old
- Patient with diagnosis of ulcerative colitis for at least 6 months.
- Patient with mayo endoscopic score ≥ 1
- Patient with mild to moderate disease activity (3 < SCCI < 12)
- Ongoing treatment by mesalamine, steroids, thiopurines or Tumor Necrosis Factor antagonist at stable dose.
- Patients who have given written informed consent.
Who cannot join
- Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
- Psychiatric disease that alter the judgment
- Stoma
- Proctocolectomy
- Severe disease (SCCI >12, acute severe colitis)
- Steroid dose > 10 mg/j or introduction of steroid (topic or oral) within 4 weeks
Show all 12Show fewer
- Introduction or dose optimization of TNF antagonist within 4 months
- Introduction or dose optimization of thiopurine
- Hemoglobin level < 11,5 g/dL, Platelets > 400000/mm3, Leukocytosis > 10 000/mm3
- Intolerant to lactose
- Disease extent limited to the rectum
- Mayo endoscopic subscore of 3
Trial locations and contacts
1 site in 1 country.
About this study
Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.
Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Probiotics in the form of cheese portion
- Keywords
- Ulcerative colitis, Probiotics, treatments, Propionibacterium freudenreichii
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics in the form of cheese portionOther
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Oral daily take of probiotics in the form of cheese portion (50g) during 8 weeks Receives: Other: Probiotics in the form of cheese portion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)
Measured: Week 8
Secondary outcomes (8)
Rate of clinical response
Measured: Week 4
Rate of clinical remission
Clinical remission rate is defined by a SCCI<3
Measured: Week 4
Rate of clinical remission
Clinical remission rate is defined by a SCCI<3
Measured: Week 8
Rate of mucosal healing
Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1
Measured: Week 8
Rate of deep (clinical and endoscopic) remission
Deep remission is defined clinically and by endoscopic exams
Measured: Week 8
Side effects
Assessment of adverse events
Measured: Week 8
Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0
Proprionibacterium freudenreichii analysis in stools
Measured: Week 8
Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0
Proprionibacterium freudenreichii analysis in stools
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start12 Feb 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488954
- Sponsor's protocol ID
- 2015-000835-34
- Other IDs
- 35RC14_9817_EMMENTAL, 2015
- Acronym
- EMMENTAL
- Status last verified
- Feb 2017
- First submitted
- 23 Jun 2015
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02488954
- Acronym / sponsor ID
- EMMENTAL / 2015-000835-34
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, Probiotics, treatments, Propionibacterium freudenreichii
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Jul 2015 (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.
Ulcerative colitis (UC) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. Thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation.
Propionibacterium freudenreichii is used for the production of fermented food products (cheese). Some selected strains have strong anti-inflammatory properties. Use of cheese based on a monoxenic culture of anti-inflammatory strain of Propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Other: Probiotics in the form of cheese portionOral daily take of probiotics in the form of cheese portion (50g) during 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with age above 18 years old
- Patient with diagnosis of ulcerative colitis for at least 6 months.
- Patient with mayo endoscopic score ≥ 1
- Patient with mild to moderate disease activity (3 < SCCI < 12)
- Ongoing treatment by mesalamine, steroids, thiopurines or Tumor Necrosis Factor antagonist at stable dose.
Key exclusion criteria (12 listed)
- Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
- Psychiatric disease that alter the judgment
- Stoma
- Proctocolectomy
- Severe disease (SCCI >12, acute severe colitis)
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 |
|---|---|---|
| Probiotics in the form of cheese portion | Other | Probiotics |
Primary outcome
Response rate
Time frame: Week 8
Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)
8 secondary outcomes
Rate of clinical response
Time frame: Week 4
Rate of clinical remission
Time frame: Week 4
Rate of clinical remission
Time frame: Week 8
Rate of mucosal healing
Time frame: Week 8
Rate of deep (clinical and endoscopic) remission
Time frame: Week 8
Side effects
Time frame: Week 8
Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0
Time frame: Week 8
Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0
Time frame: Week 8
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
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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 study testing Probiotics in the form of cheese portion in people with Ulcerative Colitis, run by Rennes University Hospital at 1 site in France.
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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Jul 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Response rate (time frame: Week 8). 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 6 Jul 2017.