Health TrialsbyHealthPanel

Effect of Procyanidins in Leaky Gut Repairing in IBD

ConditionUlcerative Colitis in Remission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Padova

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

● 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

Trial design

Design model

Single group

Treatments tested in this trial

  • Grape Seed Extracts

    Biological/Vaccine

    2 capsules/day for 8 weeks

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Active supplementExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
9 months

Secondary outcomes

1

● 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.

Time frame
10 months
2

● 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)

Time frame
10 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Padova

Lead sponsor

Source ClinicalTrials.gov
Apply now