Ulcerative colitis Digestive System
Conditions
Interventions
At the screening visit (Week -2), patients will sign the informed consent and will be assessed according to the inclusion and exclusion criteria. Blood tests and fecal calprotectin measurements will b
Sponsors
Dicofarm S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years at the time of enrollment 2. Ability to understand the study and provide informed consent 3. Diagnosis of ulcerative colitis at least 3 months prior to enrollment 4. Clinically active mild-to-moderate ulcerative colitis, defined as a Partial Mayo Score of 3–7 with a rectal bleeding subscore = 1 at baseline 5. Permitted Concomitant Medications 6. Oral and topical mesalazine
Exclusion criteria
Exclusion criteria: 1. Clinically active severe ulcerative colitis, defined as a Partial Mayo Score > 7 2. Use of probiotics and/or systemic antibiotic therapy within the previous 4 weeks 3. Pregnancy or breastfeeding 4. History of severe renal, hepatic, cardiac, or metabolic disease 5. Inability to comply with study procedures 6. Prohibited Concomitant Medications 7. Systemic, low-bioavailability oral, or topical corticosteroids 8. Immunosuppressants such as azathioprine, 6-mercaptopurine, methotrexate 9. Biologic therapy for UC (infliximab, adalimumab, golimumab, vedolizumab) 10. Tofacitinib 11. Systemic antibiotic therapy 12. Use of probiotics
Countries
Italy
Contacts
Public ContactMaurizio Vecchi
Outcome results
None listed