Nutrition Research Center, Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
Nutrition Research Center, Department of Clinical Nutrition, School of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
Trials. 2020 Aug 5;21(1):698. doi: 10.1186/s13063-020-04615-5.
Irritable bowel syndrome (IBS) is one of the most frequent and recurrent gastrointestinal diseases. However, up to now, no pharmacological agent has been approved to treat IBS. Emerging evidence showed that inflammation has a vital role in enhancing nervous system sensitivity and perception of abdominal pain in subjects with IBS. Propolis is an herbal substance with a broad spectrum of antioxidants, anti-inflammatory, and prebiotic properties, which might exert beneficial effects to reduce the severity of IBS. The current clinical trial aims to evaluate the efficacy of propolis supplementation on IBS.
This single-center, randomized, double-blind, placebo-controlled clinical trial will be performed to evaluate the effect of propolis supplementation in adult patients with IBS diagnosed with Rome IV criteria. Fifty-two eligible patients will randomly be allocated to receive a propolis tablet (450 mg, containing 100 mg polyphenol compounds) or identical placebo, twice daily for 6 weeks. The primary outcome of the trial is an improvement in IBS severity from baseline to the sixth week of intervention. The secondary outcomes include the change in weight, waist circumference, and IBS quality of life. We will use the paired sample t test or Mann-Whitney U test for the within-group comparison and independent sample t test or Wilcoxon rank-sum and chi-square test or Fisher's exact test for the between-group comparison. Besides, a multivariable-adjusted mean effect will be computed using the ANCOVA test.
We hypothesize that propolis supplementation would be useful for treating IBS through its antioxidants, anti-inflammatory, and prebiotic properties. This trial will show the results of propolis supplementation, whether positive or negative, on IBS. If the current trial confirms our hypothesis, propolis supplementation can be a new choice in adjunctive therapy of IBS.
Iranian Registry of Clinical Trials IRCT20190708044154N1. Registered on 26 December 2019. Updated on 13 February 2020. https://en.irct.ir/trial/40983 SPONSOR: Tabriz University of Medical Sciences, Tabriz, Iran.
肠易激综合征（IBS）是最常见和最常复发的胃肠道疾病之一。然而，到目前为止，还没有批准任何药物来治疗 IBS。新出现的证据表明，炎症在增强 IBS 患者的神经系统敏感性和腹痛感知方面起着至关重要的作用。蜂胶是一种具有广谱抗氧化、抗炎和益生元特性的草药物质，可能对减轻 IBS 的严重程度有有益的影响。本临床试验旨在评估蜂胶补充剂对 IBS 的疗效。
本单中心、随机、双盲、安慰剂对照临床试验将评估蜂胶补充剂对符合 Rome IV 标准诊断的 IBS 成年患者的疗效。将 52 名合格患者随机分为两组，分别接受蜂胶片（450mg，含 100mg 多酚化合物）或相同的安慰剂，每天两次，共 6 周。试验的主要结局是从基线到干预的第六周 IBS 严重程度的改善。次要结局包括体重、腰围和 IBS 生活质量的变化。我们将使用配对样本 t 检验或 Mann-Whitney U 检验进行组内比较，独立样本 t 检验或 Wilcoxon 秩和检验和卡方检验或 Fisher 精确检验进行组间比较。此外，还将使用 ANCOVA 检验计算多变量调整后的平均效应。
我们假设蜂胶补充剂通过其抗氧化、抗炎和益生元特性对治疗 IBS 是有用的。本试验将显示蜂胶补充剂对 IBS 的积极或消极结果。如果本试验证实了我们的假设，蜂胶补充剂可以成为 IBS 辅助治疗的新选择。
伊朗临床试验注册中心 IRCT20190708044154N1。于 2019 年 12 月 26 日注册。于 2020 年 2 月 13 日更新。https://en.irct.ir/trial/40983。
大不里士医科大学，大不里士，伊朗。
