NCT07724990 A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2025-05-14 with a primary completion date of 2026-09-14.

Brief 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 Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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