Molino Silvia, De Lellis Lorenza Francesca, Morone Maria Vittoria, Cordara Marcello, Larsen Danaè S, Piccinocchi Roberto, Piccinocchi Gaetano, Baldi Alessandra, Di Minno Alessandro, El-Seedi Hesham R, Sacchi Roberto, Daglia Maria
R&D Unit, Silvateam S.p.A., 12080 San Michele Mondovì, Italy.
Department of Pharmacy, University of Naples "Federico II", Via D. Montesano 49, 80131 Naples, Italy.
Nutrients. 2025 Jan 31;17(3):552. doi: 10.3390/nu17030552.
: Irritable Bowel Syndrome (IBS) is a disorder of the gut-brain axis for which the gastroenterologist is most often consulted. Gastrointestinal symptoms and decreased quality of life lead to a considerable burden of disease. The exact causes of IBS are not well understood, and no standard therapy has been established. The primary outcome of the study focused on the improvements of the IBS symptoms assessed through the validated questionnaire IBS-Severity Scoring System (IBS-SSS). Similarly, secondary outcomes geared towards the improvement of the quality of life (IBS-Quality of Life (IBS-QoL) and the Gastrointestinal Quality of Life Index (GIQLI)) and specific IBS symptoms (bloating, abdominal distension, feeling of heaviness, abdominal pain, and flatulence), were assessed through self-administered questionnaires. Intestinal habits (consistency and frequency of depositions) through subject stratification into diarrhoea (IBS-D), constipation (IBS-C), mixed type (IBS-M), as well as the treatment tolerability were also evaluated. : A randomised, placebo-controlled, double-blind, clinical trial was conducted on 156 enrolled IBS patients (79 female and 77 male), aged 18-70 years, randomised (1:1 allocation ratio) to receive either two capsules per day of the food supplement (containing 480 mg of a complex of tannin extracts) or a placebo for 56 days. Linear random intercept mixed models (LMM) were used to analyse all experimental variables : Supplementation resulted in a significant improvement ( < 0.05) in the primary outcome IBSS score, with respect to the placebo group, changing the IBS condition going from mild (242.3 ± 89.8) to moderate (148.1 ± 60.6). Similarly, all indicators concerning quality of life, and specific intestinal symptoms resulted in a significant improvement ( < 0.05). Furthermore, the tannin-based treatment showed the ability to modulate the response to different symptomatology such as diarrhoea and constipation, without side effects being reported. : The use of a supplement based on chestnut and quebracho tannins presents great application potential in the management of IBS-related disorders, with the peculiarity of resolving opposite symptoms, such as diarrhoea and constipation, indiscriminately.
肠易激综合征(IBS)是一种肠脑轴紊乱疾病,胃肠病学家经常会被咨询相关问题。胃肠道症状和生活质量下降导致了相当大的疾病负担。IBS的确切病因尚未完全明确,也没有确立标准的治疗方法。该研究的主要结局聚焦于通过经过验证的问卷——肠易激综合征严重程度评分系统(IBS-SSS)评估的IBS症状的改善情况。同样,通过自我管理问卷评估了旨在改善生活质量(IBS生活质量(IBS-QoL)和胃肠道生活质量指数(GIQLI))以及特定IBS症状(腹胀、腹部膨隆、沉重感、腹痛和气胀)的次要结局。通过将研究对象分层为腹泻型(IBS-D)、便秘型(IBS-C)、混合型(IBS-M)来评估肠道习惯(排便的稠度和频率),同时也评估了治疗耐受性。
对156名年龄在18至70岁之间的入组IBS患者(79名女性和77名男性)进行了一项随机、安慰剂对照、双盲临床试验,这些患者被随机(1:1分配比例)分为两组,一组每天服用两粒食品补充剂胶囊(含有480毫克单宁提取物复合物),另一组服用安慰剂,为期56天。使用线性随机截距混合模型(LMM)分析所有实验变量。
与安慰剂组相比,补充剂使主要结局IBS-SS评分有显著改善(P<0.05),IBS病情从轻度(242.3±89.8)转变为中度(148.1±60.6)。同样,所有关于生活质量和特定肠道症状的指标都有显著改善(P<0.05)。此外,基于单宁的治疗显示出能够调节对不同症状(如腹泻和便秘)的反应的能力,且未报告有副作用。
使用基于栗木和柯巴栲单宁的补充剂在IBS相关疾病的管理中具有很大的应用潜力,其特点是能够不加区分地解决相反的症状,如腹泻和便秘。