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

NCT02488954 | Terminated

• 2 other identifiers: 2015-000835-3435RC14_9817_EMMENTAL
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Probiotics; treatments; Propionibacterium freudenreichii

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response rate is defined by a decrease of at least two points of the Simple Clinical Colitis Index (SCCI)

  Week 8

Secondary Outcomes (8)

• Rate of clinical response

  Week 4

• Rate of clinical remission

  Week 4

• Rate of clinical remission

  Week 8

• Rate of mucosal healing

  Week 8

• Rate of deep (clinical and endoscopic) remission

  Week 8

Study Arms (1)

Probiotics

EXPERIMENTAL

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

Other: Probiotics in the form of cheese portion

Interventions

Probiotics in the form of cheese portion OTHER

Probiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 2, 2015
• Study Start: February 12, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-02

Locations

FR (1)