Fecal Microbiota Transplantation in Patients with Ulcerative Colitis Incompletely Responding to Vedolizumab

Purpose of this study?

Treatment response to FMT in UC in patients not or incompletely responding to vedolizumab

Inclusion Criteria:

·     Established diagnosis of UC

·     Active disease (total Mayo score ≥ 4 and endoscopic subscore > 1)

·     Ongoing therapy with vedolizumab for at least 14 weeks.

·     Stable dose of concomitant medication

Exclusion Criteria:

·     Co-infections with enteric pathogens

·     Fulminant colitis with intravenous steroid therapy or fever > 38.5 ºC

·     Untreated IBD associated dysplasia

·     Any previous colectomy, ostomy, or J-pouch

·     Severe concomitant diseases as decompensated liver cirrhosis or active malignancy

Primary outcome measures:

To determine changes in the bacterial taxonomic and metabolic composition after FMT

Secondary outcome measures:

To determine the presence and abundance of particular taxa in UC patients at baseline that influence engraftment of the donor microbiota

• To determine specific donor strains and its metabolites that are permanently introduced in the patients’ microbiota using strain-level metagenomics shotgun sequence analysis
• Evaluate rate of clinical response, clinical remission and mucosal healing at day 28 and day 90 after FMT
• Characterize clinical factors that are associated with treatment outcome in patients

Study Locations in Europe:

Austria

Estimated Study Completion Date: December, 2023

Further information on  www.drks.de with trial number DRKS00010910

VV-MEDMAT-69169