Effect of Procyanidins in Leaky Gut Repairing in IBD

NCT06576700 | Recruiting

• 1 other identifier: 5908/AO/24
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 capsules/day of Ecovitis for eight weeks Visit the clinic two times for checkups, serum collection, and Questionaire.

Conditions

Ulcerative Colitis in Remission

Keywords

Microbiota; proanthocyanidine; polyphenols

Outcome Measures

Primary Outcomes (1)

• ● 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 Outcomes (2)

• ● Evaluation of intestinal permeability (Leaky Gut-Zonulin test )

  10 months

• ● Evaluation of quality of life IBDQ ( test IBDQ)

  10 months

Study Arms (1)

Active supplement

EXPERIMENTAL

Treatment: the capsules contains Grape Seed Extract GSE-0001- Proanthocyanidins \<95%)

Biological: Grape Seed Extracts

Interventions

Grape Seed Extracts BIOLOGICAL

2 capsules/day for 8 weeks

Also known as: EcoVitis

Active supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• ● 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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Edoardo Vincenzo Savarino

Padua, Padua, 35128, Italy

RECRUITING

Study Officials

• Edoardo V Savarino, MD, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edoardo V. Savarino, MD; PhD

CONTACT

0498218720; edoardo.savarino@unipd.it

Sonia Facchin, PhD

CONTACT

0498218720; sonia.facchin@unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot,open label, single-treatment trial in which the enrolled subjects will be included in a one-year period, after the written informed consent collection. 25 UC patients in remission phase, both males and females, will be included in a one-year period, after the written informed consent collection. Patients will be treated with the Ecovitis extract. Patients will be asked to take 2 capsules per day, away from meals, for 8 weeks. The therapy undertaken could not be changed nor stopped during the supplement administration.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: June 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 12, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)