CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Double-blind, Controlled Pilot Clinical Trial.
CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Double-blind, Controlled Pilot Clinical Trial.
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CSP01，一种新型的高吸水性水凝胶，在一项随机、双盲、对照的初步临床试验中缩短慢性特发性便秘患者的结肠通过时间。
DOI：
10.5056/jnm20001
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发表时间：
2020-09-30
影响因子：
3.4
通讯作者：
Kuo B
中科院分区：
文献类型：
--
作者：
Staller K;Barshop K;Vélez C;Bailey A;Locascio JJ;Chiquette E;Kuo B
CSP 01是一种新型高吸收性水凝胶，可吸收胃肠液并保持高粘弹性，进入结肠，这些液体在结肠中释放。我们进行了一项单中心、随机、双盲、平行组、安慰剂对照的初步研究，比较了接受CSP 01水凝胶、活性对照（羧甲基纤维素[CMC]）或安慰剂治疗21天的慢性特发性便秘（CIC）和肠易激综合征伴便秘（IBS-C）患者的结肠通过时间（CTT）变化。在治疗前和治疗结束时，使用无线运动胶囊传输测试测量CTT。主要终点是CTT的变化。入组了40例受试者（20例CSP 01、11例CMC、9例安慰剂），38例完成了研究。各治疗组的平均CTT无显著变化（P = 0.297）。在安慰剂组中，基线和治疗结束之间的CTT增加了15.3分钟，CMC增加了366.4分钟，CSP 01减少了727.4分钟。在CIC患者的事后分析中，CSP 01组的平均CTT降低了1079分钟（与安慰剂相比，P = 0.025），CMC组降低了919分钟（与安慰剂相比，P = 0.117），安慰剂组增加了1113分钟。在IBS-C患者中，任何治疗组的CTT变化均无显著差异。CSP 01组1例受试者发生便秘所致背痛，在未进行第二次CTT测量的情况下退出研究;无其他不良事件。结论与安慰剂相比，CSP 01可显著降低CIC患者的CTT，但对IBS-C患者无影响。
CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released. We conducted a single-center, randomized, double-blind, parallel-group, placebo-controlled pilot study comparing change in colonic transit time (CTT) among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo. CTT was measured using wireless motility capsule transit testing at pre-treatment and end-of-treatment. The primary endpoint was change in CTT. Forty subjects (20 CSP01, 11 CMC, 9 placebo) were enrolled and 38 completed the study. There was no significant change in mean CTT by treatment group (P = 0.297). In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01. In post hoc analyses among those with CIC, mean CTT decreased by 1079 minutes for CSP01 (P = 0.025 compared to placebo), 919 minutes for CMC (P = 0.117 compared to placebo) and increased by 1113 minutes for placebo. Among patients with IBS-C, there was no significant difference in change in CTT for any treatment group. One subject in the CSP01 arm developed back pain attributed to constipation and withdrew without a second CTT measurement; there were no other adverse events. Conclusion CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not in patients with IBS-C.
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