Clinical trial NCT02488954: Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
Official title: Interest of Propionibacterium Freudenreichii for the Treatment of Mild to Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Probiotics
treatments
Propionibacterium freudenreichii
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Response rate
timeFrame: Week 8
Secondary outcomes:
measure: Rate of clinical response
timeFrame: Week 4
measure: Rate of clinical remission
timeFrame: Week 4
measure: Rate of clinical remission
timeFrame: Week 8
measure: Rate of mucosal healing
timeFrame: Week 8
measure: Rate of deep (clinical and endoscopic) remission
timeFrame: Week 8
measure: Side effects
timeFrame: Week 8
measure: Rate of response based on presence of Proprionibacterium freudenreichii in stools at week 0
timeFrame: Week 8
measure: Remission rate based on presence of Proprionibacterium freudenreichii in stools at week 0
timeFrame: Week 8
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References: