Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Probiotics in the form of cheese portion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotics<br>Oral daily take of probiotics in the form of cheese portion (50g) during 8 weeks | Other: Probiotics in the form of cheese portion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI) | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical response |  | Week 4 | 
| Rate of clinical remission | Clinical remission rate is defined by a SCCI<3 | Week 4 | 
| Rate of clinical remission | Clinical remission rate is defined by a SCCI<3 | Week 8 | 
| Rate of mucosal healing | Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1 | Week 8 | 
| Rate of deep (clinical and endoscopic) remission | Deep remission is defined clinically and by endoscopic exams | Week 8 | 
| Side effects | Assessment of adverse events | Week 8 | 
| Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0 | Proprionibacterium freudenreichii analysis in stools | Week 8 | 
| Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0 | Proprionibacterium freudenreichii analysis in stools | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, Probiotics, treatments, Propionibacterium freudenreichii