Ulcerative Colitis in RemissionEcoVitisNCT06576700
Effect of Procyanidins in Leaky Gut Repairing in IBD
A study testing Grape Seed Extracts in people with Ulcerative Colitis in Remission, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis in Remission
- What is being tested?
- Grape Seed Extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2024to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ● 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Edoardo Vincenzo Savarino
Padua, Padua, 35128
Edoardo V. Savarino, +39.049.8217749, edoardo.savarino@unipd.it
Sonia Facchin, sonia.facchin@unipd.it
About this study
Official title: 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.
Read the 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, the investigators will evaluate the effect of a new grape seed extract on microbiota modulation and leaky gut reduction in IBD patients.
- Conditions
- Ulcerative Colitis in Remission
- Being tested
- Grape Seed Extracts
- Keywords
- Microbiota, proanthocyanidine, polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractsBiological
Also called EcoVitis
2 capsules/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active supplement | Experimental | Treatment: the capsules contains Grape Seed Extract GSE-0001- Proanthocyanidins <95%) Receives: Biological: Grape Seed Extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
● 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.
Measured: 9 months
Secondary outcomes (2)
● Evaluation of intestinal permeability (Leaky Gut-Zonulin test )
The serum zonulin( normal value 20-48 ng/ml) 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.
Measured: 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(QoL) of IBD patients, will be proposed. ( IBDQ \<170 bad QoL; IBDQ\>/= 170 better QoL)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start15 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edoardo V Savarino, MD, PhD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576700
- Sponsor's protocol ID
- 5908/AO/24
- Acronym
- EcoVitis
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Procyanidins in the Leaky Gut Repairing Associated with Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06576700
- Acronym / sponsor ID
- EcoVitis / 5908/AO/24
- Conditions
- Ulcerative Colitis in Remission
- Keywords
- Microbiota, proanthocyanidine, polyphenols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, the investigators will evaluate the effect of a new grape seed extract on microbiota modulation and leaky gut reduction in IBD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active supplement | Experimental | Biological: Grape Seed ExtractsTreatment: the capsules contains Grape Seed Extract GSE-0001- Proanthocyanidins <95%) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence.
Key exclusion criteria (5 listed)
- ● Patients that have active UC, determined by clinical, endoscopic and histopathological evidences
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grape Seed ExtractsAlso: EcoVitis2 capsules/day for 8 weeks | Biological | Active supplement |
Primary outcome
● Evaluation of the gut microbiota composition and variation (microbiota test)
Time frame: 9 months
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.
2 secondary outcomes
● Evaluation of intestinal permeability (Leaky Gut-Zonulin test )
Time frame: 10 months
● Evaluation of quality of life IBDQ ( test IBDQ)
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo V Savarino, MD, PhD principal investigator
University of Padova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Seed Extracts in people with Ulcerative Colitis in Remission, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edoardo V. Savarino, MD; PhD (0498218720 ext. 0039, edoardo.savarino@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
● Evaluation of the gut microbiota composition and variation (microbiota test) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.