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NCT06324591Recruitment Completed

Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients

Multicentre Observational Cohort Study in Newly Diagnosed Crohn's Disease Patients Aimed at Identifying Intestinal Microbial Profiles Correlated With Low and High Risk of Severe Disease Course
Meyer Children's Hospital IRCCSClinicalTrials.govother
Verified
Study focus
Disease/Condition
Crohn Disease
Drug/Device/Intervention
Collection biological sample and analysis
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Meyer Children's Hospital IRCCS
Location
Graz,Bologna,Florence, Austria,Italy
Timeline & enrollment
Phase
N/A
Start date
Feb 03, 2021
End date
Dec 31, 2024
Enrollment
30 participants
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
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease of small intestineCrohn disease [regional enteritis]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06324591
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.