Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients - Trial NCT06324591
Access comprehensive clinical trial information for NCT06324591 through Pure Global AI's free database. This phase not specified trial is sponsored by Meyer Children's Hospital IRCCS and is currently Recruitment Completed. The study focuses on Crohn Disease. Target enrollment is 30 participants.
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Study Focus
Sponsor & Location
Meyer Children's Hospital IRCCS
Timeline & Enrollment
N/A
Feb 03, 2021
Dec 31, 2024
Primary Outcome
Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy)
Summary
Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is
 characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in
 childhood. Relevant studies have provided evidence of a key role of gut microbial communities
 (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut
 dysbiosis as the main event disrupting the balance of microbial communities Recent evidence
 suggests that, in addition to the bacterial component, the commensal fungal component also
 plays a crucial role in CD.
 
 The purpose of this prospective, longitudinal, study is to characterise the composition of
 intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn
 Disease in order to identify a possible association of specific faecal microbial profiles
 with a severe or mild-to-moderate disease course.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06324591
Non-Device Trial