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.
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
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)
Single group
For a bipsies
Diagnostic testFor the collection of a few additional biopsies
rectal administration
Dietary supplementrectal administration of a specific probiotic
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing
The primary aim of this study is to evaluate the effect of rectal administered a specific probiotic on gut microbiota in patients with UC and CD for Rectal Mucosal Healing with mayo score. Rectal mucosal healing assessed by Mayo Endoscopic Subscore (MES) (range 0-3; lower scores indicate better mucosal healing and lower disease activity).
Evaluate the tolerability of rectal a specific probiotic in Rectal Mucosal healing
Tolerability of rectally administered probiotic assessed by the incidence of adverse events and treatment discontinuations.
Evaluate the quality of life
Quality of life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) (range 32-224; higher scores indicate better quality of life).
evaluate the feasibility of a specific probiotic
To evaluate the feasibility of a specific probiotic rectal administration in a cohort of patients with mild-to-moderate ulcerative colitis by nursing notes
Click on the lead sponsor to view all of their trials.
