Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
Not applicable · Testing Prolife · 1 site · University of Padova
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Prolife (a dietary supplement) as a possible treatment. Condition(s) listed: Ulcerative Colitis in Remission.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2024-05-15.
- Main results expected around 2025-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Main thing being measured
- Evaluation of the gut microbiota composition variation (microbiota test) (From enrollment to the end of treatment 8 weeks)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis in Remission |
| Lead sponsor | University of Padova |
| Enrollment | 70 (estimated) |
| Start date | 2024-05-15 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2024-10-15 |
| Last updated | 2024-10-15 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06642883 |
Interventions
- Prolife (Dietary Supplement)
randomized in a 1:1 ratio to treatment :1 vial/day for 60 days. - Placebo (Dietary Supplement)
Placebo: 1 vial/day for 60 days.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Edoardo Vincenzo Savarino | Padua, Padua | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.