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

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.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Probiotics in the form of cheese portion

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of clinical response		Week 4
Rate of clinical remission	Clinical remission rate is defined by a SCCI<3	Week 4
Rate of clinical remission	Clinical remission rate is defined by a SCCI<3	Week 8
Rate of mucosal healing	Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1	Week 8
Rate of deep (clinical and endoscopic) remission	Deep remission is defined clinically and by endoscopic exams	Week 8
Side effects	Assessment of adverse events	Week 8
Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0	Proprionibacterium freudenreichii analysis in stools	Week 8
Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0	Proprionibacterium freudenreichii analysis in stools	Week 8

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Probiotics; Ulcerative colitis; treatments; Propionibacterium freudenreichii
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2015-000835-34; 35RC14_9817_EMMENTAL (Other Identifier: CHU de Rennes)