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A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
Sponsor: Catholic University of the Sacred Heart
Summary
Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.
Official title: A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-05-14
Completion Date
2027-05-14
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
For a bipsies
For the collection of a few additional biopsies
rectal administration
rectal administration of a specific probiotic
Locations (1)
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, RM, Italy