Probiotics In Colorectal Cancer Patients

Summary

Design: double blind controlled randomized trial with a parallel design and 3 treatment groups Description of subjects: Patients admitted in study centers for colorectal surgery under laporoscopy and/or laparotomy. Product: Product 1: BB536 and LA1 (10E9) Product 2: BB536 and LA1 (10E7) Placebo: Maltodextrin Number of patients: enrolled subjects: n=33, ITT data set: n=31, PP data set: n=30 Primary objective: Colonization (biopsy+stools) of each bacteria for one of the dose at D0 (surgical procedure) Secondary objectives: * Influence of the probiotic bacteria on the gut microflora * Modulation of the immune and inflammatory response Additional objectives: * Investigate dose effect on La1 colonization * Investigate the effect of La1 colonization, treatment without La1 colonization, and absence of treatment and La1 colonization on other bacteria and on immunological parameters

Timeline

Start

2006-10

Primary completion

2007-06

Completion

2007-10

Drugs

Indications