Effect of Procyanidins in the Leaky Gut Repairing Associated With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- ● Evaluation of the gut microbiota composition and variation (microbiota test)
研究概览
简要总结
The goal of this clinical trial is to learn if the Grape Seed Extract Ecovitis, featuring low monomeric catechins content and a high concentration of oligo-polymeric procyanidins, could modulate the Gut Microbiota composition of Ulcerative Colitis patients during the remission phase. The main questions it aims to answer are:
Does Ecovitis improve the microbiota composition in patients with Ulcerative colitis? Is the intestinal permeability affected? What about the variation in the quality of life?
Participants will:
Take 2 capsules/day of Ecovitis for eight weeks Visit the clinic two times for checkups, serum collection, and Questionaire.
详细描述
The leaky gut is an alteration of the intestinal epithelium capable of compromising the functionality of the intestinal barrier, permitting the entry of foods or viral/bacterial proteins, and then stimulating the immune system's response. This phenomenon leads to the activation of one or more inflammatory cascades, and it has been associated with the development of various pathologies and associated disorders. The leakage in the leaky gut may be responsible for a huge variety of health issues, ranging from minor (bloating, cramps, fatigue, food allergies, sensitivities, gas, and headaches) to "bigger things": autoimmune conditions, depression, and other mood disorders, diabetes, inflammatory bowel disease (IBD), and multiple sclerosis. Recent studies have shown that procyanidins have a protective effect on the intestinal barrier. Procyanidins, as a kind of dietary flavonoid, have excellent pharmacological properties, such as antioxidant, antibacterial, anti-inflammatory, and anti-tumor properties, so they could be used to treat various diseases, including Alzheimer's disease, diabetes, rheumatoid arthritis, tumors, and obesity. In particular, in vitro studies showed that procyanidins act on tight junctions and, for this reason, they could be able to modify the pathogenic cascade of various gastrointestinal pathologies, including those already mentioned, where the leaky gut plays an important role.
Grape Seed Extracts (GSEs) contain variable amounts of polyphenols and so-called oligomeric proanthocyanidins (PACs). GSEs have been investigated in several health conditions, including cardiovascular disease (CVDs) prevention, chronic venous insufficiency (CVI) management, and type 2 diabetes. Finally, it is known that the Intestinal Microbiota plays a decisive role in the degradation of PACs, but it is unknown which is the effect of PACs on the microbiota itself and its metabolic potential.
In this pilot study, we will evaluate the effect of a new grape seed extract on microbiota modulation and leaky gut reduction in IBD patients.
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
- 否
入选标准
- •Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.
- •Age between 18 and 75 years old
- •Ability of subject to participate fully in all aspects of this clinical trial.
排除标准
- •● Patients that have active UC, determined by clinical, endoscopic and histopathological evidences
- •Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis
- •Positive stool culture for active C. difficile
- •Pregnant women
- •Patients under antibiotic and/or probiotic treatment within 10 days prior to Visit 1.
研究组 & 干预措施
Active supplement
Treatment: the capsules contains Grape Seed Extract GSE-0001- Proanthocyanidins <95%)
干预措施: Grape Seed Extracts (Biological)
结局指标
主要结局
● Evaluation of the gut microbiota composition and variation (microbiota test)
时间窗: 9 months
Collection of faecal sample for the assessment of the faecal microbiota composition ribosomal ribonucleic acid ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
次要结局
- ● Evaluation of intestinal permeability (Leaky Gut-Zonulin test )(10 months)
- ● Evaluation of quality of life IBDQ ( test IBDQ)(10 months)