Nutritional Sciences Division, King's College London, London, UK.
Gut. 2011 Jul;60(7):923-9. doi: 10.1136/gut.2010.232025. Epub 2011 Jan 24.
The commensal intestinal microbiota drive the inflammation associated with Crohn's disease. However, bacteria such as bifidobacteria and Faecalibacterium prausnitzii appear to be immunoregulatory. In healthy subjects the intestinal microbiota are influenced by prebiotic carbohydrates such as fructo-oligosaccharides (FOS). Preliminary data suggest that FOS increase faecal bifidobacteria, induce immunoregulatory dendritic cell (DC) responses and reduce disease activity in patients with Crohn's disease.
To assess the impact of FOS in patients with active Crohn's disease using an adequately powered randomised double-blind placebo-controlled trial with predefined clinical, microbiological and immunological end points. Patients with active Crohn's disease were randomised to 15 g/day FOS or non-prebiotic placebo for 4 weeks. The primary end point was clinical response at week 4 (fall in Crohn's Disease Activity Index of ≥ 70 points) in the intention-to-treat (ITT) population.
103 patients were randomised to receive FOS (n = 54) or placebo (n = 49). More patients receiving FOS (14 (26%) vs 4 (8%); p = 0.018) withdrew before the 4-week end point. There was no significant difference in the number of patients achieving a clinical response between the FOS and placebo groups in the ITT analysis (12 (22%) vs 19 (39%), p = 0.067). Patients receiving FOS had reduced proportions of interleukin (IL)-6-positive lamina propria DC and increased DC staining of IL-10 (p < 0.05) but no change in IL-12p40 production. There were no significant differences in the faecal concentration of bifidobacteria and F prausnitzii between the groups at baseline or after the 4-week intervention.
An adequately powered placebo-controlled trial of FOS showed no clinical benefit in patients with active Crohn's disease, despite impacting on DC function. ISRCTN50422530.
共生肠道微生物群会引发炎症，进而导致克罗恩病。然而，双歧杆菌和普拉梭菌等细菌似乎具有免疫调节作用。在健康个体中，肠道微生物群会受到诸如低聚果糖（FOS）等益生元碳水化合物的影响。初步数据表明，FOS 可增加粪便双歧杆菌，诱导免疫调节树突状细胞（DC）反应，并降低克罗恩病患者的疾病活动度。
采用充分功率的随机双盲安慰剂对照试验，使用预先设定的临床、微生物学和免疫学终点，评估 FOS 在活动期克罗恩病患者中的作用。将活动期克罗恩病患者随机分为每天 15 克 FOS 或非益生元安慰剂组，疗程 4 周。主要终点为意向治疗（ITT）人群在第 4 周时的临床反应（克罗恩病活动指数下降≥70 分）。
103 例患者被随机分配接受 FOS（n=54）或安慰剂（n=49）治疗。接受 FOS 治疗的患者中有更多患者（14 例[26%]比 4 例[8%]；p=0.018）在 4 周终点前退出。在 ITT 分析中，FOS 组和安慰剂组的临床反应患者比例无显著差异（12 例[22%]比 19 例[39%]，p=0.067）。接受 FOS 治疗的患者的 IL-6 阳性固有层 DC 比例降低，IL-10 染色的 DC 增加（p<0.05），但 IL-12p40 产生无变化。两组患者的粪便双歧杆菌和普拉梭菌丰度在基线或 4 周干预后均无显著差异。
FOS 的充分功率安慰剂对照试验并未显示出对活动期克罗恩病患者的临床益处，尽管其影响了 DC 功能。ISRCTN50422530。
