A randomized, double-blind, controlled study and pooled analysis of two identical trials of fermented milk containing probiotic Bifidobacterium lactis CNCM I-2494 in healthy women reporting minor digestive symptoms

Background The probiotic fermented milk (PFM) containing Bifidobacterium lactis CNCM I-2494 improved gastrointestinal (GI) well-being and digestive symptoms in a previous trial involving women reporting minor digestive symptoms. Our objective is to confirm these findings in a second study and in a pooled analysis of both studies. Methods In this double-blind, controlled, parallel design study, subjects without diagnosed GI disorders consumed PFM or control dairy product daily for 4weeks. Endpoints comprised weekly assessment of GI well-being (primary endpoint), rate of responders and digestive symptoms. Data were analyzed on full analysis set population (n=324) and on the pooled data of randomized subjects of this study with those of the first study (n=538). Key Results In this second study, no significant difference was observed in the percentage of women reporting an improvement in GI well-being [OR=1.20 (95% CI 0.87, 1.66)] and rate of responders [OR=1.38 (95% CI 0.89, 2.14)]. Composite score of digestive symptoms was significantly (P<0.05) reduced in PFM when compared to the control group [LSmean=0.42 (95% CI 0.81, 0.03)]. In the pooled analysis, significant differences were observed in favor of PFM group for all endpoints: percentage of women with improved GI well-being [OR=1.36 (95% CI 1.07, 1.73)], rate of responders [OR=1.53 (95% CI 1.09, 2.16)] and composite score of digestive symptoms [LSmean=0.48 (95% CI 0.80, 0.16)]. Conclusions & Inferences This second study did not confirm improvement on the primary endpoint. However, a pooled analysis of the two trials showed improvement in GI well-being and digestive symptoms in women reporting minor digestive symptoms.