Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome.
Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome.
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DOI：
10.1136/gutjnl-2017-315136
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发表时间：
2019-06
期刊：
影响因子：
24.5
通讯作者：
Verne, G. Nicholas
中科院分区：
文献类型：
--
作者：
Zhou, Qiqi;Verne, Meghan L.;Fields, Jeremy Z.;Lefante, John J.;Basra, Sarpreet;Salameh, Habeeb;Verne, G. Nicholas
感染后腹泻为主的肠易激综合征（IBS-D）患者需要更有效的治疗。因此，我们进行了一项随机、双盲、安慰剂对照、为期8周的试验，以评估口服谷氨酰胺治疗肠感染后肠通透性增加的IBS-D患者的疗效和安全性。符合条件的成年人被随机分配到谷氨酰胺组（5g/t.i.d）或安慰剂组，持续8周。主要终点是肠易激综合征严重程度评分系统（IBS-SS）降低≥50分。次要终点包括：原始IBS-SS评分、每日排便频率的变化、大便形式（布里斯托大便量表）和肠通透性。54名谷氨酰胺和52名安慰剂受试者完成了为期8周的研究。谷氨酰胺组有43人（79.6%）出现主要终点，安慰剂组有3人（5.8%）出现主要终点（差异为14倍）。谷氨酰胺还降低了所有次要终点指标：8周时IBS-SS评分（301比181，p<0.0001），每日排便频率（5.4比2.9±1.0,p<0.0001）， Bristol大便评分（6.5比3.9,p<0.0001）和肠通透性（0.11比0.05,p<0.0001）。谷氨酰胺组的“肠道高渗透性”（尿乳果糖/甘露醇比例升高）恢复正常，但对照组没有。两组的不良事件和研究药物停药率都很低且相似。未观察到严重不良事件。在肠感染后肠高通透性的IBS-D患者中，口服膳食谷氨酰胺补充剂显著且安全地降低了所有ibs相关的主要终点。现在应该进行大型随机对照试验来验证这些发现，评估生活质量的益处，并探索药理学机制。
More effective treatments are needed for patients with post-infectious, diarrhea-predominant, irritable bowel syndrome (IBS-D). Accordingly, we conducted a randomized, double-blind, placebo-controlled, 8-week-long trial to assess the efficacy and safety of oral glutamine therapy in patients who developed IBS-D with increased intestinal permeability following an enteric infection. Eligible adults were randomized to glutamine (5g/t.i.d.) or placebo for 8 weeks. The primary end point was a reduction of ≥50 points on the Irritable Bowel Syndrome Severity Scoring System (IBS-SS). Secondary endpoints included: raw IBS-SS scores, changes in daily bowel movement frequency, stool form (Bristol Stool Scale), and intestinal permeability. Fifty-four glutamine and fifty-two placebo subjects completed the 8 week study. The primary endpoint occurred in 43 (79.6%) in the glutamine group and 3 (5.8%) in the placebo group (a 14-fold difference). Glutamine also reduced all secondary endpoint means: IBS-SS score at 8 weeks (301 vs. 181, p<0.0001), daily bowel movement frequency (5.4 vs. 2.9±1.0, p<0.0001), Bristol Stool Scale (6.5 vs. 3.9, p<0.0001) and intestinal permeability (0.11 vs. 0.05; p<0.0001). “Intestinal hyperpermeability” (elevated urinary lactulose/mannitol ratios) was normalized in the glutamine but not the control group. Adverse events and rates of study-drug discontinuation were low and similar in the two groups. No serious adverse events were observed. In IBS-D patients with intestinal hyperpermeability following an enteric infection, oral dietary glutamine supplements dramatically and safely reduced all major IBS-related endpoints. Large RCTs should now be done to validate these findings, assess quality of life benefits, and explore pharmacologic mechanisms.
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