Extrait

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

Critère d'inclusion

• Colorectal Cancer

Liens

• ictrp
• nct