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
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 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
Treatments tested in this trial
- Prolife
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov