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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: Participants are randomly allocated to the following two arms (randomisation ratio 1:1). Intervention group: Probiotics (Lactobacillus plantarum 299® [5 x 10^9 cfu] plus Bifidobacterium Cure 21® [5 x 10^9 cfu]) administrated orally (p.o.), twice a day for 3 weeks Control group: Placebo (p.o.) twice a day for 3 weeks The final clinical and laboratory examination is carried out at the end of treatment (at 3 weeks). A further evaluation will be carried out by a questionnaire 3 weeks after the end of treatment. CONDITION: Ulcerative colitis ; Digestive System ; Ulcerative colitis PRIMARY OUTCOME: The following will be assessed at baseline and end of treatment (3 weeks):; 1. Types of bacterial species in the pelvic pouch, analysed by non‐culture dependent techniques, such as Terminal‐Restriction Fragment Length Polymorphism (T‐RFLP); 2. Markers of mucosal inflammation in faeces: calprotectin, lactoferrin, myeloperoxidase (MPO) and eosinophil cationic protein (ECP); 3. Inflammation of the lining of the rectum and colon, assessed by biopsies ; 4. Immunological response patterns, assessed by examination of leukocytes in blood samples SECONDARY OUTCOME: 1. Clinical pouch function is evaluated by a questionnaire before and within 3 days from the end of treatment; 2. Pouch biopsies are evaluated by standard histopathology before and within 3 days from the end of treatment 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.
Epistemonikos ID: 7fba1e172c1a3d58a97039522693f2d3caa75150
First added on: Aug 22, 2024