Kitakyushu Hospital Group, Fukuoka 803-8501, Japan.
World J Gastroenterol. 2013;19(14):2162-70. doi: 10.3748/wjg.v19.i14.2162.
To investigate the effects of the probiotic Bifidobacterium longum BB536 on the health management of elderly patients receiving enteral feeding.
Two double-blind, placebo-controlled trials were performed with long-term inpatients receiving enteral tube feeding at Kitakyushu Hospital Group, Fukuoka, Japan. BB536 was administered as BB536-L and BB536-H powders that contained approximately 2.5 × 10¹⁰ and 5 × 10¹⁰ cfu of BB536, respectively. In the first trial, 83 patients (age range: 67-101 years) were randomized into 2 groups that received placebo (placebo group) or BB536-H (BB536 group) powders. In the second trial, 123 patients (age range: 65-102 years) were randomized into 3 groups, and each group received placebo (placebo group), BB536-L (BB536-L group), or BB536-H (BB536-H group) powders. Each patient received the study medication for 16 wk after 1 wk of pre-observation. Fecal samples were collected from each patient prior to and after the intervention during Trial 2. Clinical observations included body temperature, occurrence of infection, frequency of defecation, and fecal microbiota.
No significant changes were observed in the frequency of defecation for either treatment in Trial 1. However, a significant change was noted in the BB536-L group (P = 0.0439) in Trial 2 but not in the placebo or BB536-H groups. Subgroup analyses based on the frequency of defecation for each patient during the pre-observation period for both trials revealed significant increases in bowel movements in patients with a low frequency of defecation and significant decreases in the bowel movements of patients with a high frequency of defecation during the intervention period in the BB536 groups. The combination of Trials 1 and 2 data revealed a modulatory effect of BB536 ingestion on the changes in bowel movements. Significantly increased bowel movements were observed in patients in the low frequency subgroup with significant intergroup differences (P < 0.01). Significantly decreased bowel movements were observed in patients in the high subgroup, but no significant intergroup differences were observed compared with the placebo group. BB536 ingestion increased the prevalence of normally formed stools. BB536 intake also significantly (P < 0.01) increased the cell numbers of bifidobacteria in fecal microbiota, and significant intergroup differences were observed at week 16. No adverse events were reported in any group.
Our results suggest that BB536 ingestion modulated the intestinal environment and may have improved the health care of elderly patients receiving enteral feeding.
研究益生菌长双歧杆菌 BB536 对接受肠内喂养的老年患者健康管理的影响。
在日本福冈市北九州市立医院集团进行了两项为期 16 周的双盲、安慰剂对照试验，入组长期接受肠内管饲的住院患者。BB536 以 BB536-L 和 BB536-H 粉末形式给予，分别含有约 2.5×10¹⁰ 和 5×10¹⁰cfu 的 BB536。在第一项试验中，83 名患者（年龄范围：67-101 岁）被随机分为 2 组，分别接受安慰剂（安慰剂组）或 BB536-H（BB536 组）粉末。在第二项试验中，123 名患者（年龄范围：65-102 岁）被随机分为 3 组，每组分别接受安慰剂（安慰剂组）、BB536-L（BB536-L 组）或 BB536-H（BB536-H 组）粉末。每位患者在预观察期结束后接受研究药物治疗 16 周。在试验 2 期间，在干预前和干预后从每位患者采集粪便样本。临床观察包括体温、感染发生、排便频率和粪便微生物群。
在试验 1 中，两种治疗方法均未观察到排便频率的显著变化。然而，在试验 2 中，BB536-L 组观察到显著变化（P=0.0439），但安慰剂或 BB536-H 组没有观察到显著变化。基于两次试验每个患者在预观察期间的排便频率的亚组分析显示，在 BB536 组中，低频率排便的患者的排便次数显著增加，高频率排便的患者的排便次数在干预期间显著减少。试验 1 和试验 2 数据的组合显示 BB536 摄入对排便变化具有调节作用。在低频率亚组中观察到显著增加的排便，且组间差异具有统计学意义（P<0.01）。在高亚组中观察到显著减少的排便，但与安慰剂组相比，组间差异无统计学意义。BB536 摄入增加了正常成形粪便的比例。BB536 摄入还显著（P<0.01）增加了粪便微生物群中双歧杆菌的细胞数量，并且在第 16 周观察到显著的组间差异。任何组均未报告不良事件。
我们的结果表明，BB536 摄入调节了肠道环境，可能改善了接受肠内喂养的老年患者的健康护理。
