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

Not Applicable

Terminated

• Conditions: Ulcerative Colitis

• Registration Number: NCT02488954
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2016-02-12
• Status Verified: 2017-02
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate	Week 8	Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)

Secondary Outcome Measures

Name	Time	Method
Rate of clinical remission	Week 8	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
Side effects	Week 8	Assessment of adverse events
Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0	Week 8	Proprionibacterium freudenreichii analysis in stools
Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0	Week 8	Proprionibacterium freudenreichii analysis in stools
Rate of clinical response	Week 4

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France