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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient with Chron's Disease | Other | Only patient with Crohn's Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection biological sample and analysis | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 3 years after beginning of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Lionetti | Meyer Children's Hospital IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine | Graz | Austria |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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|
| Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification |
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 |
| 3 years after beginning of the study |
| Ospedale Maggiore-Azienda Usl Di Bologna | Bologna | Italy |
| Meyer Children's Hospital IRCCS | Florence | Italy |
| D007410 | Intestinal Diseases |