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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn Disease
- Sponsor
- Meyer Children's Hospital IRCCS
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- 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)
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS
Eligibility Criteria
Inclusion Criteria
- •Children/young people aged between 6 and 18 years with newly diagnosed CM according to recognised diagnostic criteria
- •Obtaining informed consent
Exclusion Criteria
- •Refusal to participate in the study.
Outcomes
Primary Outcomes
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)
Time Frame: 3 years after beginning of the study
Detection of differences in alpha and beta diversity in stool microbiome in various phases of disease course, at diagnosis, remission and after one year of mantainance therapy
Secondary Outcomes
- Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk(3 years after beginning of the study)
- Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification(3 years after beginning of the study)