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

Sponsor

Rennes University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02488954

Collaborator

(none)

Enrollment

Location

Arm

16.6

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Other: Probiotics in the form of cheese portion	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 12, 2016

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotics Oral daily take of probiotics in the form of cheese portion (50g) during 8 weeks	Other: Probiotics in the form of cheese portion

Arm

Intervention/Treatment

Experimental: Probiotics

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

Other: Probiotics in the form of cheese portion

Outcome Measures

Primary Outcome Measures

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

Rate of clinical response [Week 4]
Rate of clinical remission [Week 4]
Clinical remission rate is defined by a SCCI<3
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
Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0 [Week 8]
Proprionibacterium freudenreichii analysis in stools
Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0 [Week 8]
Proprionibacterium freudenreichii analysis in stools

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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