Effect of Procyanidins in Leaky Gut Repairing in IBD (EcoVitis)

Effect of Procyanidins in the Leaky Gut Repairing Associated With Inflammatory Bowel Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis in Remission
• Intervention / Treatment: Biological: Grape Seed Extracts

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edoardo V. Savarino, MD; PhD; Phone Number: 0039 0498218720; Email: edoardo.savarino@unipd.it
• Study Contact Backup: Name: Sonia Facchin, PhD; Phone Number: 0039 0498218720; Email: sonia.facchin@unipd.it

Study Locations

• Italy
  • Padua, Italy, 35128
    • Recruiting
    • Edoardo Vincenzo Savarino
    • Contact: Edoardo V. Savarino; Phone Number: +39.049.8217749; Email: edoardo.savarino@unipd.it
    • Contact: Sonia Facchin; Email: sonia.facchin@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active supplement; Treatment: the capsules contains Grape Seed Extract GSE-0001- Proanthocyanidins <95%)	Biological: Grape Seed Extracts; 2 capsules/day for 8 weeks; Other Names: EcoVitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
● Evaluation of the gut microbiota composition and variation (microbiota test)	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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
● Evaluation of intestinal permeability (Leaky Gut-Zonulin test )	The serum zonulin test allows for the evaluation of intestinal permeability, as zonulin, a protein produced by intestinal cells, when released, causes an increase in the permeability of tight junctions.	10 months
● Evaluation of quality of life IBDQ ( test IBDQ)	The validated IBDQ-32 test, consisting of 32 questions related to the quality of life of IBD patients, will be proposed.	10 months

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Edoardo V Savarino, MD, PhD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 12, 2026

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Microbiota, proanthocyanidins, polyphenols
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antioxidants; Grape Seed Extract
• Other Study ID Numbers: 5908/AO/24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No