Neurogastroenterol Motil：益生菌改善女性轻微消化症状

　　此前的一项在轻微消化道症状的女性中进行的含乳双歧杆菌CNCM I-2494的益生菌酸奶（PFM）改善了胃肠道（GI）健康状况及消化症状。近日，来自法国的一项双盲、对照、平行设计的研究旨在分析并确定上述观点。研究中没有明确主要终点的改善。不过，两项试验的合并分析显示具有轻微消化症状的女性中GI健康状况及消化症状改善。该文2013年3月11日在线发表于《神经胃肠病学与自动力》（Neurogastroenterol Motil）杂志。

　　这项双盲、对照、平行设计的研究中，未诊断GI疾病的对象每日饮用PFM或对照奶制品共4周。终点包括每周评价GI健康状况（主要终点）、有效率及消化症状。在本研究的全分析集人群（n=324）以及本研究与第一项研究的随机化对象（n=538）的合并资料中进行了数据分析。

　　关键结果第二项研究中，报告GI健康状况改善的女性百分比[OR=1.20（95%CI 0.87-1.66）]和有效率[OR=1.38（95%CI 0.89-2.14）]没有明显差异。与对照组相比，PFM组的消化症状复合评分明显降低（P<0.05）[LS平均值= -0.42（95% CI -0.81,-0.03）]。合并分析中，各项终点均观察到支持PFM组的明显差异：GI健康状况改善女性的百分比 [OR=1.36 (95% CI 1.07, 1.73)]，有效率 [OR=1.53 (95% CI 1.09, 2.16)] 及消化症状的复合评分[LS平均值=-0.48 (95% CI -0.80, -0.16)]。

与益生菌相关的拓展阅读：

• Am J Clin Nutr：对围手术期结直肠癌患者 益生菌减小感染风险
• Helicobacter：益生菌具抑制Hp感染能力
• JAMA：益生菌的服用与抗菌素使用所致的腹泻风险的降低有关
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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

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.