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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Probiotics in the form of cheese portion
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Probiotics, treatments, Propionibacterium freudenreichii

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotics

Arm Description

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

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
June 23, 2015
Last Updated
July 3, 2017
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02488954
Brief Title
Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
Acronym
EMMENTAL
Official Title
Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
February 12, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, Probiotics, treatments, Propionibacterium freudenreichii

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Oral daily take of probiotics in the form of cheese portion (50g) during 8 weeks
Intervention Type
Other
Intervention Name(s)
Probiotics in the form of cheese portion
Primary Outcome Measure Information:
Title
Response rate
Description
Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Rate of clinical response
Time Frame
Week 4
Title
Rate of clinical remission
Description
Clinical remission rate is defined by a SCCI<3
Time Frame
Week 4
Title
Rate of clinical remission
Description
Clinical remission rate is defined by a SCCI<3
Time Frame
Week 8
Title
Rate of mucosal healing
Description
Mucosal Healing is defined by a Mayo endoscopic subscore of 0 or 1
Time Frame
Week 8
Title
Rate of deep (clinical and endoscopic) remission
Description
Deep remission is defined clinically and by endoscopic exams
Time Frame
Week 8
Title
Side effects
Description
Assessment of adverse events
Time Frame
Week 8
Title
Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0
Description
Proprionibacterium freudenreichii analysis in stools
Time Frame
Week 8
Title
Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0
Description
Proprionibacterium freudenreichii analysis in stools
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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