Modulation of the gut microbiome in patients with ulcerative colitis
Summary description of the study
The aim of this study is to investigate the effects and tolerability of administering selected probiotic gut bacteria to individuals with ulcerative colitis. Included are patients who currently have no symptoms (remission) or only show mild symptoms. It will be investigated how the gut microbiome changes with this treatment and what effects this has on certain parameters in blood and stool as well as on the quality of life of the patients. The planned duration of the study is 36 months, for participants a total of 7 visits are planned over a period of 32 weeks, each lasting 1-2 hours.
(BASEC)
Intervention under investigation
Oral intake of freeze-dried probiotic bacteria/dietary supplements
(BASEC)
Disease under investigation
Ulcerative colitis in remission or with mild disease course
(BASEC)
• ≥ 18 years old on the day of signing the informed consent • Confirmed diagnosis of ulcerative colitis ≥ 6 months, confirmed by endoscopy • Remission or mild disease, defined by a partially adjusted Mayo score (MMS) ≤ 3 (BASEC)
Exclusion criteria
• Individuals with Crohn's disease, presence or history of fistulas, indeterminate colitis, infectious/ischemic colitis, microscopic colitis, or celiac disease. • Current signs of toxic megacolon, fulminant colitis, or intestinal perforation. • Recent (within the last 3 months) or planned bowel surgeries or history of proctocolectomy or partial resection of the colon or current stoma or pouch placement. (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
CRO Raffeiner
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Michael Scharl
+ 41 44 255 3419
michael.scharl@clutterusz.chAbteilung für Gastroenterologie und Hepatologie Universitätsklinik Zürich Rämistrasse 100 CH 8091 Zürich Schweiz
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
17.05.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Modulation of the Gut Microbiome in Ulcerative Colitis Patients (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available