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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
Author(s) -
Marteau P.,
Guyonnet D.,
Lafaye de Micheaux P.,
Gelu S.
Publication year - 2013
Publication title -
neurogastroenterology and motility
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.489
H-Index - 105
eISSN - 1365-2982
pISSN - 1350-1925
DOI - 10.1111/nmo.12078
Subject(s) - medicine , probiotic , gastroenterology , population , randomized controlled trial , clinical endpoint , bifidobacterium , fermentation , food science , biology , lactobacillus , genetics , environmental health , bacteria
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.