Utility of the Administration of Tannin Specific Natural Extract, Chesnut and Quebracho Based, for Irritable Bowel Syndrome Diarrhea Predominant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)
研究概览
简要总结
Irritable bowel syndrome is a highly prevalent disorder and consumes many health resources. Its physiopathogenesis is multifactorial. Some of the factors involved have to do with the alteration of the intestinal microbiota, low-grade inflammation and the alteration of intestinal permeability. Specific tannins have been shown to have prebiotic effects and could be useful in treating this condition. This is an exploratory before-after study that aims to evaluate the effect of a chestnut and quebracho extract on the symptoms of IBS diarrhea predominant, serum cytokine levels, microbiota and intestinal permeability, as well as on metabolomics.
详细描述
In vitro studies have shown that chestnut and quebracho extract has a prebiotic effect of modulating the intestinal microbiota, but also, bacterial fermentation produces metabolites with powerful anti-inflammatory effects such as quecetin. Irritable bowel syndrome (IBS) is a multifactorial disorder involving factors related to the intestinal microbiota, low-grade inflammation, and impaired intestinal permeability.
In this study, 30 patients with predominant IBS diarrhea and 50 healthy controls will be included. IBS patients will receive chestnut and quebracho extract twice a day for 8 weeks. They will be measured at baseline and at 8 weeks: 27 serum pro and anti-inflammatory cytokines and serum zonulin. Likewise, the intestinal microbiota and metabolomics will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IBS patients: Both sexes with a diagnosis of irritable bowel syndrome variety diarrhea according to the Rome IV criteria
- •Healthy Controls: Relatives of patients who do not show any disease, who do not take medication or present symptoms.
排除标准
- •patients with digestive tract disease,
- •systemic diseases such as severe heart, kidney or liver failure,
- •history of previously known digestive tract surgeries and / or intestinal adhesions,
- •diabetes mellitus,
- •cirrhosis,
- •inflammatory bowel disease,
- •celiac disease,
- •patients with cognitive impairment,
- •alcoholics,
- •lack of consent .
- •patients who have received antibiotics in the last month.
研究组 & 干预措施
IBS PATIENTS
Natural specific tannin, chestnut
干预措施: ARBOX (QUEBRACHO AND CHESNUT EXTRACT) (Dietary Supplement)
结局指标
主要结局
Change in Irritable bowel syndrome symptoms severity (IBS severity score, 75-500)
时间窗: 60 days
Change in IBS severity score from baseline
Change in Stool frequency (number of deposition per day)
时间窗: 60 days
Change in stool frequency per day from baseline
Change in Stool consistency (Bristol stool form scale, 1-7)
时间窗: 60 days
Change in Stool consistency from baseline
次要结局
- Change in Intestinal microbiota(60 days)
- Change in Inflammation(60 days)
- Change in Intestinal permeability(60 days)
研究者
Maria Marta Piskorz
Neurogastroenterologist at Hospital de Clinicas, Principal Investigator
Hospital de Clinicas José de San Martín