Overview
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.
Description
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, the investigators will evaluate the effect of a new grape seed extract on microbiota modulation and leaky gut reduction in IBD patients.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- ● 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.