Crohn Disease
Conditions
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.
Interventions
OTHERCollection biological sample and analysis
collection of a stool sample collected at clinical practice check-ups during the first year after diagnosis of Crohn's disease. This is followed by the evaluation of clinical, laboratory and instrumental data at the time of diagnosis
Sponsors
Meyer Children's Hospital IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk |
| Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification | 3 years after beginning of the study | Indentification of different patterns of intestinal microbiome (alpha and beta diversity, microbial richness and relative abundance of microbial species) as a potential biomarker for high and low risk patients |
Countries
Austria, Italy
Outcome results
None listed