Valutation of the efficacy of Lactobacillus casei subspeciae casei DG in prevention of Crohn s disease relapse after induction of clinical remission by antibiotics a multicentric, randomised, double-blind, placebo-controlled study

INTERVENTION: Trade Name: A07FA01‐ Organismi produttori di acido lattico ( fermenti lattici ) Product Name: Enterolactis Plus Product Code: DG 01/05 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Lactic acid producing organisms Current Sponsor code: 2005‐002418‐39 Other descriptive name: ENTEROLACTIS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 420‐ CONDITION: prevention of Crohn s disease relapse ; MedDRA version: 6.1 Level: PT Classification code 10011401 PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range