Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576700
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Effect of Procyanidins in Leaky Gut Repairing in IBD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Procyanidins in the Leaky Gut Repairing Associated with Inflammatory Bowel Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EcoVitis
Brief Summary:
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 capsulesday of Ecovitis for eight weeks Visit the clinic two times for checkups serum collection and Questionaire
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 capsulesday of Ecovitis for eight weeks Visit the clinic two times for checkups serum collection and Questionaire
Detailed 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 viralbacterial proteins and then stimulating the immune system39s 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 Alzheimers 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None