Evaluation of ProLife 10 FORTE on Gut Microbiota Composition in UC Patients
Launched by UNIVERSITY OF PADOVA · Oct 14, 2024
Trial Information
Current as of August 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating whether a probiotic called ProLife 10 FORTE can improve the gut bacteria in patients with Ulcerative Colitis (UC) who are currently in remission. The research aims to find out if taking this probiotic can lead to healthier gut bacteria, understand changes in the bacteria's activity, and see how these changes might relate to the patients' health conditions. Participants will take either ProLife 10 FORTE or a placebo (a harmless look-alike substance) for 60 days and will need to visit the clinic twice for checkups and tests.
To be eligible for this trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of UC that is currently in remission, and be able to participate fully in the study. However, individuals with active UC or certain other gastrointestinal conditions, pregnant women, and those with allergies to ingredients in the probiotic are not eligible. This trial is actively recruiting participants and aims to help improve understanding of gut health in people with UC.
Gender
ALL
Eligibility 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.
About University Of Padova
The University of Padova, a prestigious research institution in Italy, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration and cutting-edge research, the university fosters an environment conducive to the development of novel therapies and treatment modalities. Its commitment to ethical standards, patient safety, and scientific rigor ensures that all clinical trials are conducted with the highest level of integrity. Through these initiatives, the University of Padova aims to contribute significantly to the global medical community and improve health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Padua, , Italy
Patients applied
Trial Officials
Edoardo V Savarino
Principal Investigator
University of Padova
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported