Ulcerative Colitis Clinical Trial
— EMMENTALOfficial title:
Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
Verified date | February 2017 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de Rennes | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI) | Week 8 | |
Secondary | Rate of clinical response | Week 4 | ||
Secondary | Rate of clinical remission | Clinical remission rate is defined by a SCCI<3 | Week 4 | |
Secondary | Rate of clinical remission | Clinical remission rate is defined by a SCCI<3 | Week 8 | |
Secondary | Rate of mucosal healing | Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1 | Week 8 | |
Secondary | Rate of deep (clinical and endoscopic) remission | Deep remission is defined clinically and by endoscopic exams | Week 8 | |
Secondary | Side effects | Assessment of adverse events | Week 8 | |
Secondary | Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0 | Proprionibacterium freudenreichii analysis in stools | Week 8 | |
Secondary | Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0 | Proprionibacterium freudenreichii analysis in stools | Week 8 |
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