RecruitingNot ApplicableNCT06576700

Effect of Procyanidins in Leaky Gut Repairing in IBD

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


Sponsor

University of Padova

Enrollment

25 participants

Start Date

Jun 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria5

  • ● 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.

Interventions

BIOLOGICALGrape Seed Extracts

2 capsules/day for 8 weeks


Locations(1)

Edoardo Vincenzo Savarino

Padua, Padua, Italy

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NCT06576700


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