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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

Authors


Address for Correspondence
Philippe Marteau, Department of digestive diseases, AP-HP, Lariboisière Hospital, University Denis Diderot, Paris 7, Paris, France.
Tel: +33 1 49 95 25 78; fax: +33 1 49 95 25 77;
e-mail: philippe.marteau@lrb.aphp.fr

Abstract

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 4 weeks. 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.

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