Probiotics In Colorectal Cancer Patients

Mise à jour : Il y a 5 ans
Référence : NCT00936572

Femme et Homme

  • | Pays :
  • Italy
  • | Organes :
  • -
  • | Spécialités :
  • -

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

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