Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
ConditionUlcerative Colitis in Remission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Padova
About this trial
This clinical trial aims to learn if the probiotic Prolife 10 Forte could improve the Gut Microbiota composition of Ulcerative colitis patients during the remission phase. The main questions it seeks to answer are:
* Does Prolife 10 Forte improve the microbiota composition in patients with Ulcerative colitis? * Is it possible to highlight the variation in microbial pathways? * What clinical parameters vary and are associated with changes in the gut microbiota? Researchers will compare Prolife 10 Forte to a placebo (a look-alike substance containing no drug) to see if the probiotics improve microbiota.
Participants will:
* Take 1 vial/day of Prolife 10 Forte /Placebo for 60 days. * Visit the clinic two times for checkups, Questionaire and tests
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 the subject to participate fully in all aspects of this clinical trial.
Disqualifiers
Patients with active UC are determined by clinical, endoscopic, and histopathological evidence.
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
Parallel
Treatments tested in this trial
Prolife
Dietary supplementrandomized in a 1:1 ratio to treatment :1 vial/day for 60 days.
Placebo
Dietary supplementPlacebo: 1 vial/day for 60 days.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Prolife 10 ForteActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the gut microbiota composition variation (microbiota test)
Collection of fecal samples to assess the fecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq, 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
From enrollment to the end of treatment 8 weeksSecondary outcomes
1
Evaluation of gut microbiota pathways variation ( Picrust analysis)
PICRUSt (Phylogenetic Investigation of Communities by Reconstruction of Unobserved States) is a bioinformatics tool used to predict the genetic functions of microbial communities based on DNA sequencing data.
Time frame
The microbiota analysis period, after 16S analysis: 2 monthsOther outcomes
1
Evaluation of clinical parameters variation ( Fecal calprotectin stool test)
The patient undergoes fecal calprotectin analysis assessment before and after the 60-day treatment. (cut-off value 50ug/g)
Time frame
From enrolment to the end of analysis: 2-3 months2
Evaluation of clinical parameters (IBDQ-32 questionnaire)
The patient undergoes IBDQ questionnaire assessment before and after the 60-day treatment. ( IBDQ-32 score; cut-off 170 pt.)
Time frame
from the enrolment to the end of analysis: 2-3 monthsSponsors and contacts
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Source ClinicalTrials.gov