Are probiotics beneficial for ulcerative colitis patients with poor pelvic pouch function?

Completed

Conditions: lcerative colitis
Digestive System
Ulcerative colitis

Registration Number: ISRCTN50513887

Lead Sponsor: Probi AB (Sweden)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Both males and females, age 18-75 years
2. Patient with a pelvic pouch because of ulcerative colitis. The pouch function should be inferior according to a clinical evaluation including a pouch function score.

Exclusion Criteria

1. Patient with a pelvic pouch, but with other diagnoses, e.g., Crohn's disease or polyposis
2. Patients with good pouch function

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be assessed at baseline and end of treatment (3 weeks):<br>1. Types of bacterial species in the pelvic pouch, analysed by non-culture dependent techniques, such as Terminal-Restriction Fragment Length Polymorphism (T-RFLP)<br>2. Markers of mucosal inflammation in faeces: calprotectin, lactoferrin, myeloperoxidase (MPO) and eosinophil cationic protein (ECP)<br>3. Inflammation of the lining of the rectum and colon, assessed by biopsies <br>4. Immunological response patterns, assessed by examination of leukocytes in blood samples

Secondary Outcome Measures

Name	Time	Method
1. Clinical pouch function is evaluated by a questionnaire before and within 3 days from the end of treatment<br>2. Pouch biopsies are evaluated by standard histopathology before and within 3 days from the end of treatment