Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

Exclusion Criteria

• •Patient who has treatment, within 3 months prior to screening, with immunomodulators including corticosteroids, azathioprine, mercaptopurine, biologics, tacrolimus, cyclosporine, for disease control.
• •Patient who has stable oral 5-ASA dose ≥ 4 gr/day treatment, within 1 month prior to screening.
• •Patient with C-reactive Protein levels (CRP) ≥ 10 mg/L
• •Patient who has anti-diarrheal treatment, within 3 months prior to screening.
• •Use of prescription medications started or with a dose adjustment within 4 weeks prior to study enrolment, or OTC medications or supplements started or with a dose adjustment within 2 weeks prior study enrolment.
• •Use of products, food supplements or medical devices, whose composition includes probiotics in the 3 months prior to the selection.
• •Patient who has fulminant or severe colitis, toxic megacolon, primary sclerosing cholangitis, Crohn's disease, history of colitis associated colonic dysplasia or active peptic ulcer disease.
• •Patient who has prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
• •Patient who has past or present fistula or abdominal abscess
• •Patient who has clinically significant diseases and/or infections captured in the medical history or evidence of clinically significant findings on physical examination and/or clinically significant ordinary laboratory evaluations (haematology, biochemistry, and urinalysis) or ECG.
• •Patient who has evidence of significant liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
• •Patient who is currently participating in another clinical trial of an investigational drug or medical device within 90 days prior to screening.
• •Patient who is pregnant or lactating
• •Inability to comply with study protocol, in opinion of the investigator
• •History of alcohol, drug or chemical abuse within 6 months prior to screening
• •History of cancer except local basal or squamous cell carcinoma of the skin that has been excised and is considered cured.