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.
Inclusion Criteria:
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:
Pregnancy and breastfeeding
antonio.gasbarrini@unicatt.it0630157104
patients with UC and CD
Multi-Strain Probiotics Supplementation With Standard Care in Mild to Moderate Ulcerative Colitis
Role of Healthy Bacteria in Ulcerative Colitis
Diet Intervention Treatment for Active Ulcerative Colitis
The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
Probiotics in GastroIntestinal Disorders
Effect of Probiotic Administration on Patients With Inflammatory Bowel Disease
Effects of Probiotics in Patients With Ulcerative Colitis
Synbiotic Treatment of Ulcerative Colitis Patients