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It is a multicenter, randomized, placebo-controlled, double-blind parallel-group trial to evaluate one pack of fermented milk per day (Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)) (n = 98) or matching placebo (n = 97) for 48 weeks in enrolled 195 enrolled patients with quiescent Ulcerative colitis (UC) (1).
Relapse-free survival (relapse: rectal bleeding score ≥ 2 on Sutherland disease activity index scale for 3 consecutive days and/or initiation of remission induction therapy for worsening of UC) (1).
An interim analysis was conducted after including and following up with one-third of the patients in the first part of the stud…