Modulation of the gut microbiome in ulcerative colitis patients

Not Applicable

• Conditions: K51; Ulcerative colitis

• Registration Number: DRKS00034330
• Lead Sponsor: Institut Allergosan Pharmazeutische Produkte Forschungs- und Vertriebs GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 24

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

•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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrate the persistent modification of the intestinal microbiome composition in the feces (stool) of patients with ulcerative colitis following Bacteria administration after 24 weeks.