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

Rennes University Hospital

Status: Terminated

Conditions: Ulcerative Colitis

Treatments: Other: Probiotics in the form of cheese portion

Study type: Interventional

Funder types: Other

Identifiers

NCT02488954

35RC14_9817_EMMENTAL (Other Identifier)

2015-000835-34

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Probiotics

Experimental group

Description:

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

Treatment:

Other: Probiotics in the form of cheese portion