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

Ulcerative Colitis Clinical Trial

— EMMENTAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02488954
• Other study ID #: 2015-000835-34
• Secondary ID: 35RC14_9817_EMME
• Status: Terminated
• Phase: N/A
• First received: June 23, 2015
• Last updated: July 3, 2017
• Start date: February 12, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: February 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Probiotics in the form of cheese portion

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)	Week 8
Secondary	Rate of clinical response		Week 4
Secondary	Rate of clinical remission	Clinical remission rate is defined by a SCCI<3	Week 4
Secondary	Rate of clinical remission	Clinical remission rate is defined by a SCCI<3	Week 8
Secondary	Rate of mucosal healing	Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1	Week 8
Secondary	Rate of deep (clinical and endoscopic) remission	Deep remission is defined clinically and by endoscopic exams	Week 8
Secondary	Side effects	Assessment of adverse events	Week 8
Secondary	Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0	Proprionibacterium freudenreichii analysis in stools	Week 8
Secondary	Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0	Proprionibacterium freudenreichii analysis in stools	Week 8