Evaluating Prolife 10 FORTE for Gut Health in Ulcerative Colitis 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
This study is testing if a probiotic called Prolife 10 Forte can improve gut health in people with Ulcerative Colitis who are in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Padova Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Padua, Padua) |
| Trial ID | NCT06642883 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether the probiotic Prolife 10 Forte can enhance the gut microbiota composition in patients with Ulcerative Colitis (UC) during remission. Participants will receive either Prolife 10 Forte or a placebo daily for 60 days, with follow-up clinic visits for assessments. The study aims to determine the effects of the probiotic on microbiota composition and associated clinical parameters, comparing results between the treatment and placebo groups. Previous research suggests that probiotics may positively influence UC management, making this trial particularly relevant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of Ulcerative Colitis in remission.
Not a fit: Patients with active Ulcerative Colitis or other specified gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gut health and management strategies for patients with Ulcerative Colitis.
How similar studies have performed: Previous studies have shown that probiotics can lead to remission in some Ulcerative Colitis patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Padua, Padua
- Edoardo Vincenzo Savarino — Padua, Padua, Italy (Recruiting)
Study contacts
- Principal investigator: Edoardo V Savarino — University of Padova
- Study coordinator: Edoardo V. Savarino, Prof.MD; PhD
- Email: edoardo.savarino@unipd.it
- Phone: 0498218720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.