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

NCT ID: NCT02488954

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-12
• Study Completion Date: 2017-06-30

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Probiotics

Oral daily take of probiotics in the form of cheese portion (50g) during 8 weeks

Group Type: EXPERIMENTAL

Probiotics in the form of cheese portion

Intervention Type: OTHER

Interventions

Probiotics in the form of cheese portion

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC14_9817_EMMENTAL

Identifier Type: OTHER

Identifier Source: secondary_id

2015-000835-34

Identifier Type: -

Identifier Source: org_study_id