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RECRUITING
NCT07724990
NA

A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis

Sponsor: Catholic University of the Sacred Heart

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

For a bipsies

For the collection of a few additional biopsies

DIETARY_SUPPLEMENT

rectal administration

rectal administration of a specific probiotic

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, RM, Italy