RecruitingNot ApplicableNCT07724990

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

A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study


Sponsor

Catholic University of the Sacred Heart

Enrollment

20 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying For a bipsies and rectal administration for people with crohn disease and ulcerative colitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFor a bipsies

For the collection of a few additional biopsies

DIETARY_SUPPLEMENTrectal administration

rectal administration of a specific probiotic


Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, RM, Italy

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NCT07724990


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