Clever Cookie Ltd, Hove, UK.
Enteromed Ltd, London, UK.
Trials. 2020 Jan 30;21(1):122. doi: 10.1186/s13063-020-4069-x.
Irritable bowel syndrome (IBS) with diarrhoea (IBS-D) is a common and chronic condition that can significantly impair quality of life. The emergence of new drugs for IBS-D has been slow and there is a need for new treatments, including drug-free treatments, which are easy to use and suitable for different patient groups. Currently available drug-free treatments include Enterosgel®, an intestinal adsorbent approved for use in IBS-D and acute diarrhoea and available over-the-counter in the UK and 30 countries worldwide. The aim of this randomised, double-blind, placebo-controlled, multi-centre study is to test the efficacy and safety of Enterosgel® compared to placebo in symptomatic treatment in IBS-D.
METHODS/DESIGN: We will recruit 430 participants with IBS-D from approximately 30 primary and secondary care sites in England. Participants meeting the required abdominal pain and stool consistency criteria over a 2-week screening period will be randomly allocated to receive blinded treatment (Enterosgel® or placebo) for 8 weeks. This will be followed by an 8-week open-label treatment phase with Enterosgel®. Participants will be allowed to adjust their daily dosage during both phases based on their symptoms. Participants will then return to standard care and those who responded to treatment will receive a follow-up call 8 weeks later. Co-medication with loperamide will be permitted and use recorded. The primary outcome measure is the percentage of participants defined as responders for abdominal pain and stool consistency during at least 4 weeks in the 8-week blinded phase. Secondary outcome measures include stool frequency, stool consistency, abdominal pain, bloating, urgency, adequate relief, questionnaire scores and rescue medication use. Exploratory outcomes will be assessed in subsets of participants including qualitative and quantitative data on faecal microorganisms and biomarkers and gut-related measurements from magnetic resonance imaging data.
This is the first large scale randomised controlled trial investigating Enterosgel® in IBS-D. A study design with blinded phase followed by an open-label phase was chosen to encourage participation and study completion. Demonstrating that Enterosgel® is effective and safe in IBS-D could encourage adoption by patients and healthcare professionals and foster future clinical trials assessing its use in related conditions.
ISRCTN17149988. Prospectively registered on 14 November 2017.
肠易激综合征伴腹泻（IBS-D）是一种常见的慢性疾病，可显著降低生活质量。治疗 IBS-D 的新药研发进展缓慢，因此需要新的治疗方法，包括非药物治疗方法，这些方法易于使用，适用于不同的患者群体。目前，非药物治疗方法包括肠内吸附剂 Enterosgel，该药已被批准用于治疗 IBS-D 和急性腹泻，并在英国和全球 30 个国家/地区的非处方药物中使用。本随机、双盲、安慰剂对照、多中心研究旨在测试 Enterosgel 与安慰剂相比在 IBS-D 症状治疗中的疗效和安全性。
方法/设计：我们将从英国约 30 个初级和二级保健中心招募 430 名 IBS-D 患者。经过为期 2 周的筛选期，符合腹痛和粪便稠度标准的患者将被随机分配接受为期 8 周的双盲治疗（Enterosgel 或安慰剂）。随后进行 8 周的开放性 Enterosgel 治疗期。在这两个阶段，患者可以根据症状调整每日剂量。然后，患者将恢复到标准治疗，对治疗有反应的患者将在 8 周后进行随访。可允许合并使用洛哌丁胺，并记录使用情况。主要结局指标是在 8 周双盲期至少 4 周内腹痛和粪便稠度的缓解率。次要结局指标包括粪便频率、粪便稠度、腹痛、腹胀、急迫感、充分缓解、问卷评分和急救药物使用情况。将在部分患者中评估探索性结局，包括粪便微生物和生物标志物的定性和定量数据以及磁共振成像数据的肠道相关测量值。
这是第一项研究 Enterosgel 在 IBS-D 中的大型随机对照试验。选择双盲期后进行开放性试验的设计，是为了鼓励患者参与并完成试验。证明 Enterosgel 在 IBS-D 中的有效性和安全性，可能会鼓励患者和医疗保健专业人员采用，并促进未来临床试验评估其在相关疾病中的应用。
ISRCTN86477539。于 2017 年 11 月 14 日进行前瞻性注册。
