K51
Conditions
Interventions
Group 1: In this study two probiotic products (OMNi-BiOTiC®) from the company Allergosan will be administered orally over a period of 6 months.
The first probiotic contains a mix of 10 probiotic bacte
Sponsors
Institut Allergosan Pharmazeutische Produkte Forschungs- und Vertriebs GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Willing and able to provide written informed consent for the trial • Confirmed diagnosis of UC = 6 months, confirmed by endoscopy • Remission or mild disease defined by partial adapted Mayo score (MMS) = 3 verified during screening period • Subjects with documented adequate response to at least one of the following treatments: • stable therapy for at least 3 months with 5-ASA, immunosuppressants, biologic therapies, JAK inhibitors, sphingosine 1-phosphate (S1P) receptor modulators and/or any new drug approved during the study period • Have adequate organ function in the opinion of the investigator • A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at screening visit.
Exclusion criteria
Exclusion criteria: • Subjects with Crohn`s disease, presence or history of fistula, indeterminate colitis, infectious/ischemic colitis, microscopic colitis or celiac disease. • Current evidence of toxic megacolon, fulminant colitis, bowel perforation. Recent (within the last 3 months) or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma or pouch. • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator • Subject with the following oral/ rectal/ s.c. / i.v. treatments within the last four weeks: prednisone or prednisone equivalents, beclomethasone dipropionate or budesonide MMX, any antibiotic therapy • Active bacterial infection requiring oral or systemic antibiotic therapy • Subjects who have completed a course of antibiotics within four weeks prior to first dosing • Intake of probiotics within four weeks prior to first dosing • Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial • Any medical condition of health disorders that prevents from participating the clinical trial in the opinion of the investigators • Serologic evidence of HIV infection, or active infection with hepatitis B or C • Any disease or syndrome causing immunodeficiency in the opinion of the treating investigator • Any malignancies within the last 2 years • Any disease requiring immunosuppressive or immunomodulatory treatment which makes the patient inapplicably for a participation in the trial in the opinion of the investigator • Patients with a BMI > 35 kg/m2 or any other condition preventing the use of the sedative propofol in the opinion of the investigator • Female subjects that are pregnant or breastfeeding at screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate the persistent modification of the intestinal microbiome composition in the feces (stool) of patients with ulcerative colitis following Bacteria administration after 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety and tolerability of continuous oral administration of Bacteria - Detection of study product (Bacteria) in stool - Alterations in the composition of the fecal microbiome, the microbiome in intestinal tissue biopsies as well as in peripheral blood mononuclear cells (PBMCs) - Alterations in serum metabolome composition in serum following study product (Bacteria) application - Alterations in immune cell composition in peripheral blood following study product (Bacteria) application - Alterations in immune cell composition and epithelial barrier function markers in the intestine following study product (Bacteria) application - Alterations in levels of serum cytokines and growth factors following study product (Bacteria) application - Fecal levels of Calprotectin as biomarkers for UC activity and intestinal barrier integrity - Alterations in the partial adapted Mayo score and the endoscopic Mayo subscore following study product (Bacteria) application - Improvement in health-related quality of life (HRQL) will be assessed using the EuroQol Health questionnaire instrument EQ-5D-5L - Improvement in bowel urgency | — |
Countries
Switzerland
Contacts
Public ContactMichael Scharl
Klinik für Gastroenterologie und Hepatologie - Universitätsspital Zürich
Outcome results
None listed