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

Recruiting now · Not applicable

Conditions studied: Ulcerative Colitis, Crohn Disease

In brief

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 facts

Study ID: NCT07724990
Run by: Catholic University of the Sacred Heart
People needed: 20
Starts: 2025-05-14
Expected to finish: 2027-05-14
Last updated by the study team: 2026-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Men or women 18 to 80 years of age at the time of consent
Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening
Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase
Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening
Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.

You may not qualify if…

concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded.
Intolerance to topical therapy (enemas)
Allergy to A. muciniphila or any other component of the IP
Crohn's disease or inflammatory bowel disease unclassified (IBD-U)
Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period.
Subject who received topical therapy (i.e., enema or suppository of aminosalicylates / corticosteroids) within 14 days prior to Screening or during the Screening period.
Subject who received fecal microbial transplantation within 3 months prior to Baseline.
Subjects with the following chronic or active infections:
Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study
Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice,
Are infected with human immunodeficiency virus (HIV),
Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
Pregnancy and breastfeeding

Where it is running

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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