Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, Probiotics, treatments, Propionibacterium freudenreichii
Brief 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. 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.
Interventions
OTHERProbiotics in the form of cheese portion
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Week 8 | Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical remission | Week 4 | Clinical remission rate is defined by a SCCI\<3 |
| Rate of mucosal healing | Week 8 | Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1 |
| Rate of deep (clinical and endoscopic) remission | Week 8 | Deep remission is defined clinically and by endoscopic exams |
| Rate of clinical response | Week 4 | — |
| Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0 | Week 8 | Proprionibacterium freudenreichii analysis in stools |
| Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0 | Week 8 | Proprionibacterium freudenreichii analysis in stools |
| Side effects | Week 8 | Assessment of adverse events |
Countries
France
Outcome results
None listed