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Clinical Trials in Italy / NCT06642883
Recruiting Not applicable

Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients

NCT06642883 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Padova
Phase
Not applicable
Started
2024-05-15
Last updated
2024-10-15

Condition(s) studied

Ulcerative Colitis in Remission

Investigational drug(s) / intervention(s)

ProlifePlacebo

Prolife: randomized in a 1:1 ratio to treatment :1 vial/day for 60 days.

Placebo: Placebo: 1 vial/day for 60 days.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 the subject to participate fully in all aspects of this clinical trial. Exclusion Criteria: * 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. * Allergy to soy or fructose (contained in Prolife 10 FORTE) * Patients under antibiotic and/or probiotic treatment within 10 days before visit1.

Primary outcome measure(s)

  • Evaluation of the gut microbiota composition variation (microbiota test) — From enrollment to the end of treatment 8 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
Edoardo Vincenzo Savarino Padua Padua Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06642883 on ClinicalTrials.gov ↗ ← All trials in Italy