A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis
- Sponsor
- Catholic University of the Sacred Heart
- Study ID
- NCT07724990
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- For a bipsies — DIAGNOSTIC_TESTFor the collection of a few additional biopsies
- rectal administration — DIETARY_SUPPLEMENTrectal administration of a specific probiotic
Study Details
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.
Key Dates
- First listed
- Jul 24, 2026
- Start date
- May 14, 2025
- Status verified
- Jul 2026
- Primary completion
- Sep 14, 2026
- Completion
- May 14, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Type of patientspatients with UC and CD
Primary Outcome Measure
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing [ Time Frame: 1 year ]
Central Contacts
- Antonio Gasbarrini0630157104
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