Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
Evaluation of the Effects of 10-strain Probiotic (ProLife 10 FORTE) on Gut Microbiota Composition in Patients Presenting with Ulcerative Colitis During the Remission Phase
University of Padova
70 participants
May 15, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- 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.
Interventions
randomized in a 1:1 ratio to treatment :1 vial/day for 60 days.
Placebo: 1 vial/day for 60 days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06642883