Using Grape Seed Extract to Repair Leaky Gut in Ulcerative Colitis Patients
Effect of Procyanidins in the Leaky Gut Repairing Associated with Inflammatory Bowel Disease
This study is testing if taking grape seed extract can help improve gut health and symptoms in people with ulcerative colitis who are in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Padova Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Padua, Padua) |
| Trial ID | NCT06576700 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if Grape Seed Extract Ecovitis can improve gut microbiota composition and intestinal permeability in patients with Ulcerative Colitis during remission. Participants will take two capsules daily for eight weeks and attend two clinic visits for checkups and assessments. The study will evaluate changes in microbiota, intestinal barrier function, and quality of life. The underlying hypothesis is that procyanidins in the extract may enhance gut health and mitigate symptoms associated with leaky gut.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of Ulcerative Colitis in remission.
Not a fit: Patients with active Ulcerative Colitis or other forms of colitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve gut health and quality of life for patients with Ulcerative Colitis in remission.
How similar studies have performed: While there is emerging evidence supporting the benefits of procyanidins for gut health, this specific approach is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Padua, Padua
- Edoardo Vincenzo Savarino — Padua, Padua, Italy (Recruiting)
Study contacts
- Principal investigator: Edoardo V Savarino, MD, PhD — University of Padova
- Study coordinator: Edoardo V. Savarino, MD; PhD
- Email: edoardo.savarino@unipd.it
- Phone: 0498218720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.